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Effecten van theta-burst-stimulatie op de hersenen, het gedrag en de klinische symptomen bij volwassenen met een bipolaire stoornis

13 oktober 2026 bijgewerkt door: Mary Phillips, MD MD (Cantab)

Opheldering van neurale mechanismen van hypo/manie met behulp van theta-burst-stimulatie

Bipolar Disorder (BD) is a common and highly debilitating psychiatric disorder, however, the predisposing brain mechanisms are poorly understood. Here, the investigators aim to examine the immediate effect of transcranial brain stimulation (TBS) on brain activity and emotions in adults with and without BD as a first stage toward understanding the predisposing brain mechanisms of BD. The investigators hypothesize that TBS will reduce brain activity while playing a game with rewards in all adults, but the TBS will reduce brain activity more in the adults with BD compared to adults without BD. Furthermore, the investigators hypothesize that this reduced brain activity will be associated with reduced BD symptoms, such as negative emotions.

Studie Overzicht

Toestand

Toestand

Geeft de huidige wervingsstatus of de uitgebreide toegangsstatus aan.
Voltooid

Conditie

Conditie

De ziekte, stoornis, syndroom, aandoening of verwonding die wordt bestudeerd. Op ClinicalTrials.gov kunnen aandoeningen ook andere gezondheidsgerelateerde problemen omvatten, zoals levensduur, kwaliteit van leven en gezondheidsrisico's.

Interventie / Behandeling

Interventie / Behandeling

Een proces of actie die centraal staat in een klinische studie. Interventies omvatten medicijnen, medische hulpmiddelen, procedures, vaccins en andere producten die in onderzoek zijn of al beschikbaar zijn. Interventies kunnen ook niet-invasieve benaderingen omvatten, zoals onderwijs of het aanpassen van voeding en lichaamsbeweging.

Gedetailleerde beschrijving

This study aims to examine the effects of noninvasive stimulation on brain activity as measured by functional magnetic resonance imaging (fMRI) in participants with and without Bipolar I Disorder. Eligible participants will undergo 5 study visits: a screening visit, a baseline MRI visit, and 3 cTBS visits. Participants will receive brain stimulation and undergo fMRI scanning at each of the 3 cTBS study visits, however, at one of the visits, the brain stimulation will be a sham. The research associates and participants will be blinded to when the sham occurs, which will be randomized beforehand. Certain information is withheld to protect the scientific integrity of the study design

Studietype

Studietype

Beschrijft de aard van een klinische studie. Onderzoekstypen omvatten interventionele studies (ook wel klinische studies genoemd), observationele studies (inclusief patiëntenregistraties) en uitgebreide toegang.
Ingrijpend

Inschrijving (Werkelijk)

Inschrijving

Het aantal deelnemers aan een klinische studie. De "verwachte" inschrijving is het beoogde aantal deelnemers dat de onderzoekers nodig hebben voor het onderzoek.
146

Fase

Fase

De fase van een klinische proef waarin een medicijn of biologisch product wordt bestudeerd, gebaseerd op definities die zijn ontwikkeld door de Amerikaanse Food and Drug Administration (FDA). De fase is gebaseerd op het doel van het onderzoek, het aantal deelnemers en andere kenmerken. Er zijn vijf fasen: vroege fase 1 (voorheen vermeld als fase 0), fase 1, fase 2, fase 3 en fase 4. Niet van toepassing wordt gebruikt om onderzoeken te beschrijven zonder door de FDA gedefinieerde fasen, inclusief onderzoeken van apparaten of gedragsinterventies.
  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • University of Pittsburgh

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Geschiktheidscriteria

De belangrijkste eisen waaraan mensen die willen deelnemen aan een klinische studie moeten voldoen of de eigenschappen die ze moeten hebben. Geschiktheidscriteria bestaan ​​uit zowel inclusiecriteria (die vereist zijn voor een persoon om deel te nemen aan het onderzoek) als uitsluitingscriteria (die voorkomen dat een persoon deelneemt). Soorten geschiktheidscriteria zijn onder meer of een onderzoek gezonde vrijwilligers accepteert, leeftijds- of leeftijdsgroepvereisten heeft, of wordt beperkt door geslacht.

Leeftijden die in aanmerking komen voor studie

18 jaar tot 35 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. All participants

    • 18-35 years of age
    • Scoring less than or equal to 8 on the Hamilton Rating Scale for Depression (HRSD) at screen visit

  2. Participants with Bipolar Disorder (BD)

    • Diagnosis of Bipolar Disorder I/II (BDI/II) (DSM-5 criteria) in remission (euthymic for >2 months) or with mild-moderate hypomania
    • <15 on the Young Mania Rating Scale
    • Not psychotic
    • <3 on delusions, hallucinations, unusual thought content, and conceptual disorganization items of the Positive and Negative Syndrome Scale (PANSS)
    • Unmedicated or on any combination (except antidepressant monotherapy) of anxiolytics (benzodiazepines, buspirone, pregabalin, hydroxyzine) as needed, and/or atypical antipsychotics, and/or lithium, and/or other mood stabilizers, and/or non-SNRI antidepressants and/or non benzodiazepine hypnotics, as these are commonly-prescribed medications for BD

  3. Participants without Bipolar Disorder

    • No present or lifetime history of BD or psychiatric disorder other than anxiety or non BD mood disorders
    • Not in a current depressive episode
    • No family history of BD

Exclusion Criteria:

  1. All participants

    • History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report)

    • Family history of epilepsy (TBS exclusion criterion)

    • Use of substances with seizure risk (e.g., stimulants) in the past month, assessed as at screening, baseline, and before each fMRI-cTBS-fMRI session

    • Mini-Mental State Examination score (cognitive state) <24

    • Premorbid National Adult Reading Test Intelligent Quotient estimate<85

    • Visual disturbance: <20/40 Snellen visual acuity

    • Left/mixed handedness

    • History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (SCID-5). Note: lifetime/present cannabis use (at non-abuse (<3 times in the past month) and non SUD levels) will be allowed, given its common usage in BD and young adults. Cannabis SUD over the last 6 months will not be allowed. Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals

    • Binge drinking in the week before, and/or >3 units/day for the 3 days before, and/or alcohol in the last 12 hrs before, any cTBS scan day, confirmed at screening and scan days (to avoid TBS during alcohol withdrawal). Alcohol/nicotine/ caffeine/cannabis use (below SCID-5 SUD, binge levels) will be allowed, and used as covariates

    • MRI exclusion criteria: metallic objects, e.g., surgical implants; claustrophobia; proneness; positive pregnancy test for females (performed at the MRRC) or self-report pregnancy

    • Inability to understand English

    • <18 years of age or >35 year of age

      • SNRI antidepressants and bupropion will not be allowed, as they can elevate seizure risk, a contraindication for TBS
      • Scoring greater than or equal to 8 on HRSD and in depressive episode is confirmed on SCID-5 at screen visit
      • Scoring greater than or equal to 18 on HRSD at any visit
      • In current depressive episode

  2. Participants with Bipolar Disorder

    • BD diagnosis other than BDI/II
    • More severe hypo/mania (YMRS>15)
    • Psychosis
    • Using psychotropic medications other than those allowed in inclusion criteria

  3. Participants without Bipolar Disorder

    • Present/ lifetime history of any psychiatric disorder other than anxiety and non BD mood disorders
    • Family history of of BD

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm

Deelnemersgroep / Arm

Een groep of subgroep van deelnemers aan een klinische studie die een specifieke interventie/behandeling krijgt, of geen interventie, volgens het protocol van de studie.
Interventie / Behandeling

Interventie / Behandeling

Een proces of actie die centraal staat in een klinische studie. Interventies omvatten medicijnen, medische hulpmiddelen, procedures, vaccins en andere producten die in onderzoek zijn of al beschikbaar zijn. Interventies kunnen ook niet-invasieve benaderingen omvatten, zoals onderwijs of het aanpassen van voeding en lichaamsbeweging.
Experimenteel: Left ventrolateral prefrontal cortex (vlPFC)/Left SS/Left vlPFC sham

A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:

  • left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
  • left SS cTBS (cTBS applied to the left somatosensory area)
  • left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Apparaat: Continuous Theta Burst Stimulation (cTBS)

cTBS is a brief stimulation of a part of the brain with a magnetic field that passes through the scalp and skull safely. It is FDA-approved as a treatment for psychological conditions including depression; however, this device is not approved for the treatment of adults with Bipolar Disorder I or for use in healthy adults. This research study is using the cTBS off label in all participants (those with and without Bipolar Disorder I) to examine research questions

Andere namen:
  • Transcraniële magnetische stimulatie (TMS)
Apparaat: Sham Continuous Theta Burst Stimulation (Sham cTBS)

Sham cTBS goes through the motions of applying cTBS to the brain but administers very low current so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells. Participants will know that one session will be a sham, but they will be blinded to which session is the sham

Andere namen:
  • Sham Transcraniële Magnetische Stimulatie (Sham TMS)
Experimenteel: Left vlPFC/Left vlPFC sham/Left SS

A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:

  • left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
  • left SS cTBS (cTBS applied to the left somatosensory area)
  • left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Apparaat: Continuous Theta Burst Stimulation (cTBS)

cTBS is a brief stimulation of a part of the brain with a magnetic field that passes through the scalp and skull safely. It is FDA-approved as a treatment for psychological conditions including depression; however, this device is not approved for the treatment of adults with Bipolar Disorder I or for use in healthy adults. This research study is using the cTBS off label in all participants (those with and without Bipolar Disorder I) to examine research questions

Andere namen:
  • Transcraniële magnetische stimulatie (TMS)
Apparaat: Sham Continuous Theta Burst Stimulation (Sham cTBS)

Sham cTBS goes through the motions of applying cTBS to the brain but administers very low current so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells. Participants will know that one session will be a sham, but they will be blinded to which session is the sham

Andere namen:
  • Sham Transcraniële Magnetische Stimulatie (Sham TMS)
Experimenteel: Left SS/Left vlPFC sham/Left vlPFC

A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:

  • left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
  • left SS cTBS (cTBS applied to the left somatosensory area)
  • left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Apparaat: Continuous Theta Burst Stimulation (cTBS)

cTBS is a brief stimulation of a part of the brain with a magnetic field that passes through the scalp and skull safely. It is FDA-approved as a treatment for psychological conditions including depression; however, this device is not approved for the treatment of adults with Bipolar Disorder I or for use in healthy adults. This research study is using the cTBS off label in all participants (those with and without Bipolar Disorder I) to examine research questions

Andere namen:
  • Transcraniële magnetische stimulatie (TMS)
Apparaat: Sham Continuous Theta Burst Stimulation (Sham cTBS)

Sham cTBS goes through the motions of applying cTBS to the brain but administers very low current so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells. Participants will know that one session will be a sham, but they will be blinded to which session is the sham

Andere namen:
  • Sham Transcraniële Magnetische Stimulatie (Sham TMS)
Experimenteel: Left SS/Left vlPFC/Left vlPFC sham

A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:

  • left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
  • left SS cTBS (cTBS applied to the left somatosensory area)
  • left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Apparaat: Continuous Theta Burst Stimulation (cTBS)

cTBS is a brief stimulation of a part of the brain with a magnetic field that passes through the scalp and skull safely. It is FDA-approved as a treatment for psychological conditions including depression; however, this device is not approved for the treatment of adults with Bipolar Disorder I or for use in healthy adults. This research study is using the cTBS off label in all participants (those with and without Bipolar Disorder I) to examine research questions

Andere namen:
  • Transcraniële magnetische stimulatie (TMS)
Apparaat: Sham Continuous Theta Burst Stimulation (Sham cTBS)

Sham cTBS goes through the motions of applying cTBS to the brain but administers very low current so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells. Participants will know that one session will be a sham, but they will be blinded to which session is the sham

Andere namen:
  • Sham Transcraniële Magnetische Stimulatie (Sham TMS)
Experimenteel: Left vlPFC sham/Left SS/Left vlPFC

A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:

  • left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
  • left SS cTBS (cTBS applied to the left somatosensory area)
  • left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Apparaat: Continuous Theta Burst Stimulation (cTBS)

cTBS is a brief stimulation of a part of the brain with a magnetic field that passes through the scalp and skull safely. It is FDA-approved as a treatment for psychological conditions including depression; however, this device is not approved for the treatment of adults with Bipolar Disorder I or for use in healthy adults. This research study is using the cTBS off label in all participants (those with and without Bipolar Disorder I) to examine research questions

Andere namen:
  • Transcraniële magnetische stimulatie (TMS)
Apparaat: Sham Continuous Theta Burst Stimulation (Sham cTBS)

Sham cTBS goes through the motions of applying cTBS to the brain but administers very low current so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells. Participants will know that one session will be a sham, but they will be blinded to which session is the sham

Andere namen:
  • Sham Transcraniële Magnetische Stimulatie (Sham TMS)
Experimenteel: Left vlPFC sham/Left vlPFC/Left SS

A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:

  • left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)
  • left SS cTBS (cTBS applied to the left somatosensory area)
  • left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Apparaat: Continuous Theta Burst Stimulation (cTBS)

cTBS is a brief stimulation of a part of the brain with a magnetic field that passes through the scalp and skull safely. It is FDA-approved as a treatment for psychological conditions including depression; however, this device is not approved for the treatment of adults with Bipolar Disorder I or for use in healthy adults. This research study is using the cTBS off label in all participants (those with and without Bipolar Disorder I) to examine research questions

Andere namen:
  • Transcraniële magnetische stimulatie (TMS)
Apparaat: Sham Continuous Theta Burst Stimulation (Sham cTBS)

Sham cTBS goes through the motions of applying cTBS to the brain but administers very low current so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells. Participants will know that one session will be a sham, but they will be blinded to which session is the sham

Andere namen:
  • Sham Transcraniële Magnetische Stimulatie (Sham TMS)

Wat meet het onderzoek?

Primaire uitkomstmaten

Primaire uitkomstmaten

In het protocol van een klinische studie, de geplande uitkomstmaat die het belangrijkst is voor het evalueren van het effect van een interventie/behandeling. De meeste klinische onderzoeken hebben één primaire uitkomstmaat, maar sommige hebben er meer dan één.
Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reward expectancy-related left ventrolateral prefrontal cortex activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted blood oxygen level-dependent (BOLD) signal from the left ventrolateral prefrontal cortex to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related right ventrolateral prefrontal cortex activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal from the right ventrolateral prefrontal cortex to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left ventral striatum activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal from the left ventral striatum to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related right ventral striatum activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal from the left ventral striatum to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left orbitofrontal cortex activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal from the left orbitofrontal cortex to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related right orbitofrontal cortex activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal from the left orbitofrontal cortex to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related midline rostral anterior cingulate cortex (rACC) activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal from the midline rostral anterior cingulate cortex (rACC) to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related midline dorsal anterior cingulate cortex activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal from the midline dorsal anterior cingulate cortex to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left amygdala activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal from the left amygdala to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related right amygdala activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal from the left amygdala to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left ventrolateral prefrontal cortex-right ventrolateral prefrontal cortex functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimate for functional connectivity between the left and right ventrolateral prefrontal cortices to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left ventrolateral prefrontal cortex-left ventral striatum functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimate for functional connectivity between the left ventrolateral prefrontal cortex and left ventral striatum to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left ventrolateral prefrontal cortex-right ventral striatum functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimate for functional connectivity between the left ventrolateral prefrontal cortex and right ventral striatum to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left ventrolateral prefrontal cortex-left orbitofrontal cortex functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimate for functional connectivity between the left ventrolateral prefrontal cortex and left orbitofrontal cortex to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left ventrolateral prefrontal cortex-right orbitofrontal cortex functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimate for functional connectivity between the left ventrolateral prefrontal cortex and right orbitofrontal cortex to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left ventrolateral prefrontal cortex-midline rostral anterior cingulate cortex functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimate for functional connectivity between the left ventrolateral prefrontal cortex and midline rACC to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left ventrolateral prefrontal cortex-midline dorsal anterior cingulate cortex functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimate for functional connectivity between the left ventrolateral prefrontal cortex and midline dorsal anterior cingulate cortex to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left ventrolateral prefrontal cortex-left amygdala functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimate for functional connectivity between the left ventrolateral prefrontal cortex and left amygdala to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Reward expectancy-related left ventrolateral prefrontal cortex-right amygdala functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimate for functional connectivity between the left ventrolateral prefrontal cortex and right amygdala to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

Secundaire uitkomstmaten

Secundaire uitkomstmaten

In het protocol van een klinische studie, een geplande uitkomstmaat die niet zo belangrijk is als de primaire uitkomstmaat voor het evalueren van het effect van een interventie, maar die nog steeds van belang is. De meeste klinische onderzoeken hebben meer dan één secundaire uitkomstmaat.
Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reward expectancy-related left ventrolateral prefrontal cortex wholebrain functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS for each cTBS condition of the extracted parameter estimate for functional connectivity between the left ventrolateral prefrontal cortex and the whole brain to the uncertain reward expectancy regressor during performance of the reward task
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventrolateral prefrontal cortex activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the left ventrolateral prefrontal cortex to the contrast of possible win vs. neutral control conditions
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Right ventrolateral prefrontal cortex activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the right ventrolateral prefrontal cortex to the contrast of possible win vs. neutral control conditions
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventral striatum activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the left ventral striatum to the contrast of possible win vs. neutral control conditions
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Right ventral striatum activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the right ventral striatum to the contrast of possible win vs. neutral control conditions
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left orbitofrontal cortex activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the left orbitofrontal cortex to the contrast of possible win vs. neutral control conditions
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Right orbitofrontal cortex activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the right orbitofrontal cortex to the contrast of possible win vs. neutral control conditions
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Midline rostral anterior cingulate cortex activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the midline rostral anterior cingulate cortex to the contrast of possible win vs. neutral control conditions
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Midline dorsal anterior cingulate cortex activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the midline dorsal anterior cingulate cortex to the contrast of possible win vs. neutral control conditions
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left amygdala activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the left amygdala to the contrast of possible win vs. neutral control conditions
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Right amygdala activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the right amygdala to the contrast of possible win vs. neutral control conditions
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventral lateral prefrontal cortex-wholebrain functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of functional connectivity between the left ventrolateral prefrontal cortex and the wholebrain to the contrast of possible win vs. neutral control conditions
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Prediction error-related left ventral striatum activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the left ventral striatum to the prediction error regressor
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Prediction error-related right ventral striatum activity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted BOLD signal in the right ventral striatum to the prediction error regressor
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Prediction error-related left ventral striatum-wholebrain functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the left ventral striatum and the wholebrian to the prediction error regressor
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Prediction error-related right ventral striatum-wholebrain functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the right ventral striatum and the wholebrain
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

Andere uitkomstmaten

Andere uitkomstmaten

Voor klinische proeven, een geplande meting beschreven in het protocol die wordt gebruikt om het effect van een interventie/behandeling op deelnemers te bepalen. Voor observationele studies, een meting of observatie die wordt gebruikt om patronen van ziekten of eigenschappen, of associaties met blootstellingen, risicofactoren of behandeling te beschrijven. Soorten uitkomstmaten zijn onder meer primaire uitkomstmaat en secundaire uitkomstmaat.
Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Left ventrolateral prefrontal cortex-wholebrain resting state functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the left ventrolateral prefrontal cortex and the wholebrain
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventrolateral prefrontal cortex-right ventrolateral prefrontal cortex resting state functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the left and right ventrolateral prefrontal cortices
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventrolateral prefrontal cortex-left ventral striatum resting state functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the left ventrolateral prefrontal cortex and the left ventral striatum
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventrolateral prefrontal cortex-right ventral striatum resting state functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the left ventrolateral prefrontal cortex and the right ventral striatum
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventrolateral prefrontal cortex-left orbitofrontal cortex resting state functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the left ventrolateral prefrontal cortex and the left orbitofrontal cortex
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventrolateral prefrontal cortex-right orbitofrontal cortex resting state functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the left ventrolateral prefrontal cortex and the right orbitofrontal cortex
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventrolateral prefrontal cortex-midline rostral anterior cingulate cortex resting state functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the left ventrolateral prefrontal cortex and the midline rostral anterior cingulate cortex
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventrolateral prefrontal cortex-midline dorsal anterior cingulate cortex resting state functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the left ventrolateral prefrontal cortex and the midline dorsal anterior cingulate cortex
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventrolateral prefrontal cortex-left amygdala resting state functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the left ventrolateral prefrontal cortex and the left amygdala
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)
Left ventrolateral prefrontal cortex-right amygdala resting state functional connectivity
Tijdsspanne: Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

The difference in magnitude between pre and post cTBS scans for each cTBS condition of the extracted parameter estimates of resting state functional connectivity between the left ventrolateral prefrontal cortex and the right amygdala
Change in magnitude immediately before and immediately after each cTBS condition at scan visits (30-60 mins)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sponsor

De organisatie of persoon die het onderzoek initieert en die autoriteit en controle heeft over het onderzoek.
Mary Phillips, MD MD (Cantab)

Medewerkers

Medewerkers

Een andere organisatie dan de sponsor die een klinische studie ondersteunt. Deze ondersteuning kan bestaan ​​uit activiteiten op het gebied van financiering, ontwerp, implementatie, data-analyse of rapportage.
National Institute of Mental Health (NIMH)

Onderzoekers

Onderzoekers

Een onderzoeker die betrokken is bij een klinische studie. Verwante termen zijn onder meer hoofdonderzoeker van de locatie, subonderzoeker van de locatie, onderzoeksvoorzitter, onderzoeksleider en hoofdonderzoeker van de studie.
  • Hoofdonderzoeker: Mary Phillips, MD, MD, University of Pittsburgh
  • Hoofdonderzoeker: Fabio Ferrarelli, MD, PhD, University of Pittsburgh

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

Studie start

De daadwerkelijke datum waarop de eerste deelnemer aan een klinische studie deelnam. De "verwachte" startdatum van de studie is de datum waarvan de onderzoekers denken dat deze de startdatum van de studie zal zijn.
6 april 2021

Primaire voltooiing (Werkelijk)

Primaire voltooiing

De datum waarop de laatste deelnemer aan een klinische studie is onderzocht of een interventie heeft ondergaan om definitieve gegevens voor de primaire uitkomstmaat te verzamelen. Of de klinische studie volgens het protocol is beëindigd of is beëindigd, heeft geen invloed op deze datum. Voor klinische onderzoeken met meer dan één primaire uitkomstmaat met verschillende voltooiingsdata verwijst deze term naar de datum waarop de gegevensverzameling voor alle primaire uitkomstmaten is voltooid. De "verwachte" primaire voltooiingsdatum is de datum waarvan de onderzoekers denken dat deze de primaire voltooiingsdatum voor het onderzoek zal zijn.
24 oktober 2025

Studie voltooiing (Werkelijk)

Studie voltooiing

De datum waarop de laatste deelnemer aan een klinisch onderzoek is onderzocht of een interventie/behandeling heeft ondergaan om definitieve gegevens te verzamelen voor de primaire uitkomstmaten, secundaire uitkomstmaten en bijwerkingen (d.w.z. het laatste bezoek van de laatste deelnemer). De "verwachte" voltooiingsdatum van de studie is de datum waarvan de onderzoekers denken dat deze de voltooiingsdatum van de studie zal zijn.
24 oktober 2025

Studieregistratiedata

Eerst ingediend

Eerst ingediend

De datum waarop de onderzoekssponsor of onderzoeker voor het eerst een onderzoeksdossier heeft ingediend bij ClinicalTrials.gov. Er is meestal een vertraging van een paar dagen tussen de eerste ingediende datum en de beschikbaarheid van het dossier op ClinicalTrials.gov (de eerste geposte datum).
18 december 2020

Eerst ingediend dat voldeed aan de QC-criteria

Eerst ingediend dat voldeed aan de QC-criteria

De datum waarop de onderzoekssponsor of onderzoeker voor het eerst een onderzoeksdossier indient dat consistent is met de beoordelingscriteria voor kwaliteitscontrole (QC) van de National Library of Medicine (NLM). De sponsor of onderzoeker moet mogelijk een of meerdere keren een onderzoeksdossier herzien en indienen voordat aan de QC-beoordelingscriteria van NLM wordt voldaan. Het is de verantwoordelijkheid van de sponsor of onderzoeker om ervoor te zorgen dat het onderzoeksdossier consistent is met de NLM QC-beoordelingscriteria.
4 januari 2021

Eerst geplaatst (Werkelijk)

Eerst geplaatst

De datum waarop het onderzoeksdossier voor het eerst beschikbaar was op ClinicalTrials.gov nadat de beoordeling van de kwaliteitscontrole (QC) van de National Library of Medicine (NLM) is afgerond. Er is meestal een vertraging van een paar dagen tussen de datum waarop de onderzoekssponsor of onderzoeker het onderzoeksdossier heeft ingediend en de eerste geposte datum.
6 januari 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

Laatste update geplaatst

De meest recente datum waarop wijzigingen in een onderzoeksdossier beschikbaar zijn gemaakt op ClinicalTrials.gov. Er kan een vertraging optreden tussen het moment waarop de wijzigingen zijn ingediend bij ClinicalTrials.gov door de sponsor of onderzoeker van het onderzoek (de datum waarop de laatste update is ingediend) en de datum waarop de laatste update is gepost.
3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

Laatste update ingediend die voldeed aan QC-criteria

De meest recente datum waarop de onderzoekssponsor of onderzoeker wijzigingen in een onderzoeksdossier heeft ingediend die in overeenstemming zijn met de beoordelingscriteria voor kwaliteitscontrole (QC) van de National Library of Medicine (NLM). Het is de verantwoordelijkheid van de sponsor of onderzoeker om ervoor te zorgen dat het onderzoeksdossier consistent is met de NLM QC-beoordelingscriteria.
13 oktober 2026

Laatst geverifieerd

Laatst geverifieerd

De meest recente datum waarop de onderzoekssponsor of onderzoeker de informatie over een klinisch onderzoek op ClinicalTrials.gov als nauwkeurig en actueel heeft bevestigd. Indien een studie met een wervingsstatus van werving; nog niet aan het werven; of actief, geen rekrutering is niet bevestigd in de afgelopen 2 jaar, de rekruteringsstatus van de studie wordt weergegeven als onbekend.
1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

Andere studie-ID-nummers

Identificatoren of ID-nummers anders dan het NCT-nummer die aan een klinisch onderzoek zijn toegewezen door de sponsor, financiers of anderen van het onderzoek. Deze nummers kunnen unieke identificatoren van andere onderzoeksregisters en subsidienummers van de National Institutes of Health bevatten.
  • STUDY20060322
  • R01MH122990 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The investigators will complete and submit a National Data Archive (NDA) Data Sharing Agreement within 6 months of the Notice of Award Issue date. Study staff will upload data dictionary to the NDA website, and will review the NDA data definition for the measures collected and define the project's data definition harmonized to that standard. For measures not yet defined, project staff will work with the NDA staff to define the measure following NDA best practices. Informed consent will be collected from study participants that allows for broad sharing of participants' de-identified data. Study staff will use participants' personally identifiable information to generate NDA Global Unique Identifier (GUID) numbers for study participants.

All data will be identified by GUID numbers only prior to submission to the NDA database. Data transfer procedures will be in accordance with all Institutional Review Board guidelines and federal regulations including HIPAA.

IPD-tijdsbestek voor delen

Raw data and data from descriptive/raw measures will be submitted on a semi-annual basis by July 15 and January 15 or the next business day. We also agree to submit to NDA the analyzed data yielded in our project (i.e., 12 months after accomplishment of each primary aim or objective, or immediately upon publication of the project's primary results, whichever occurs first). The PIs reserve the right to publish on the stated aims in a timely manner during the period of the award. Data will be available for addressing other research questions (i.e. which are not described in funded/pending grants) as soon as the data have been checked for accuracy (a period which will be no later than one year after the completion of each assessment). After the award has ended, the study investigators will continue to test the stated aims, but will also continue to solicit collaborations with outside researchers and to consider data requests in a timely manner.

IPD-toegangscriteria voor delen

Outside investigators must submit a 1)proposal of the study aims, hypotheses, variables/constructs, analytic approach, and estimated duration of the proposed research; 2)resume, qualifications, source of financial support, and conflict of interest statement; 3)sign a data-sharing agreement and confidentiality statement that stipulates using the data for the stated research purposes only, securing the data using appropriate computer technology, not manipulating the data in order to identify participants, acknowledging the grant that supported data collection and management in publications/presentations, and destroying or returning the data after analyses are complete; 4)obtain approval from their Institutional Review Board, and along with other staff members who have access to the data, submit certificates of the University of Pittsburgh Education and Certification Program in Research Practice Fundamentals or provide written documentation pf similar human subjects protection training.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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