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- Register voor klinische proeven in de VS.
- Klinische proef NCT04824105
Angstige coping moduleren
Modelleren en moduleren van ontsnappings-, vermijdings- en naderingsmechanismen in het angststoornisspectrum
This is a study to find out if a device that temporarily alters brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how people with anxiety or related concerns cope with feared or anxiety-producing situations. The study is recruiting people who recently started treatment for anxiety or a related concern. The study involves 3 visits to the Medical University of South Carolina. At the first visit, participants do interviews and surveys asking about anxiety and related concerns, and they also do tasks where they see and react to emotional pictures while their brain activation is measured. At the next two visits, participants receive rTMS, which works by rapidly turning a focused magnetic field on and off repeatedly over the head in a way that passes directly through the hair, scalp, and skull and onto the brain and can temporarily increase brain activity under the magnetic field. After rTMS, participants do two tasks where they see and react to emotional situations while wearing sensors on their hand, arms, face, and head.
Each visit in this study is expected to last between 2 - 4 hours. This is not a treatment study, but the study is being conducted with the hope that it will help improve treatment in the future.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Christopher T Sege, PhD
- Telefoonnummer: 8437928465
- E-mail: sege@musc.edu
Studie Locaties
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29425
- Werving
- Medical University of South Carolina
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Contact:
- Christopher T Sege
- Telefoonnummer: 978-764-1480
- E-mail: sege@musc.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 18 - 65 y.o.
- Meets criteria for an anxiety disorder (Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Specific Phobia), posttraumatic stress disorder, obsessive- compulsive disorder, or current adjustment disorder with anxiety
- Is currently seeking mental health treatment
- Is able to read consent document and provide informed consent.
- English is a first or primary fluent language.
Exclusion Criteria:
- Current alcohol or substance use disorder of more than mild severity (as defined by DSM-5 and determined using standardized self-report instruments)
- Lifetime diagnosis of psychotic disorder or bipolar mania
- Presence of neurological disorder that contraindicates TMS or neurophysiological recording: Seizure disorder Lifetime history of traumatic brain injury with loss of consciousness Neurodegenerative disorder (e.g., Alzheimer's Disease, Parkinson's Disease, Frontotemporal Dementia)
- Presence of other medical disorder that would make it too uncomfortable to sit or lie still for long recording periods
- Presence of standard contraindications for MRI or rTMS Metal in the body Currently pregnant Claustrophobia Significant sensitivity to noise Medical conditions or treatments that lower seizure threshold History of severe brain injury History of seizures/ epilepsy
- Currently taking anticholinergic mediation, neuroleptic medication, or sedative/ hypnotic medication Note: SSRI, cholinesterase inhibitors or NMDA receptor antagonists are allowed if patient has been on a stable regimen of four weeks prior to enrollment
- Currently taking chronic opiate medications or substances
- Currently taking naltrexone
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Neurostimulation Group
On one study day, participants will complete experimental tasks during functional magnetic resonance imaging. On two other study days, participants will complete tasks before and after receiving repetitive transcranial magnetic stimulation (rTMS). All participants will receive rTMS to ventromedial prefrontal cortex on one study day, and to pre-supplementary motor area on another study day. Two stimulation procedures will be used, one for ventromedial prefrontal cortex and one for pre-supplementary motor area. For both targets, 3 sessions of 600 pulses at 110% of resting motor threshold will be presented over 30 minutes. For ventromedial cortex, a session will involve intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. For pre-supplementary motor area, a session will involve continuous theta burst presented in 3-pulse bursts with 15 pulses/ sec. |
A repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System will be used to deliver intermittent theta burst to ventromedial prefrontal cortex, and continuous theta burst to pre-supplementary motor area. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Fear-Potentiated Startle Reflex
Tijdsspanne: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Fear-potentiated startle is measured during an experimental task in which participants prepare to avoid, escape, or simply be exposed to aversive pictures. Fear-potentiated startle measures motivational activation during the preparation period. |
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Change in Speed to Initiate Avoidance Behavior
Tijdsspanne: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Reaction time to initiate flight is measured in an experimental task in which participants can win money but also must evade a slow, moderate, or fast virtual predator. Reaction time measures behavioral tendency to approach or avoid. |
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Escape/ Avoidance Electroencephalography
Tijdsspanne: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Electroencephalography (EEG) is measured during an experimental task in which participants prepare to avoid, escape, or simply be exposed to aversive pictures. An event-related potential, the stimulus-preceding negativity, will be derived from the EEG to index action preparation processing. |
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Change in Approach/ Avoidance Conflict Electroencephalography
Tijdsspanne: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Electroencephalography (EEG) is measured during an experimental task in which participants can win money but also must evade a slow, moderate, or fast virtual predator. A frequency signature, power in the theta frequency band, will be derived from the EEG to index cognitive control processes. |
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Change in Task-Related Heart Rate Changes
Tijdsspanne: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Heart rate is measured during experimental tasks in which: 1) participants prepare to avoid, escape, or simply be exposed to aversive pictures; 2) participants can win money but also must evade a slow, moderate, or fast virtual predator. Heart rate slowing measures task-related engagement of attention, while heart rate increase indicates defensive activation. |
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Change in Task-Related Skin Conductance Responding
Tijdsspanne: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Skin conductance is measured during experimental tasks in which: 1) participants prepare to avoid, escape, or simply be exposed to aversive pictures; 2) participants can win money but also must evade a slow, moderate, or fast virtual predator. Skin conductance increases indicate task-related sympathetic arousal. |
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Change in Task-Related Perceived Control
Tijdsspanne: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Perceived control over aversive stimuli is queried after an experimental task in which participants prepare to avoid, escape, or simply be exposed to aversive pictures. Perceived control for each condition is queried using self-report Likert-type scales for each condition. |
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Change in Difficulty of Avoiding Task-Based Aversive Exposure
Tijdsspanne: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Difficulty of avoiding exposure to aversive stimulation is queried after each trial during a task in which participants can win money but also must evade a slow, moderate, or fast virtual predator. Avoidance difficulty is queried using a Likert-type scale delivered after each trial. The scale ranges from 1 to 5, with higher scores indicating greater perceived difficulty of avoiding capture by the virtual predator. |
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Change in State Anxiety During Session
Tijdsspanne: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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State-level anxiety is measured throughout the experimental session using the State-Trait Anxiety Inventory - State Form. The State-Trait Anxiety Inventory - State Form uses 20 items querying anxiety symptom experience in the present moment to measure how anxiety fluctuates across the experimental session. The scale ranges from 20 to 80, with higher scores indicating higher state anxiety. |
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Task-Related Brain Activation
Tijdsspanne: During Session (Approx. 45 minutes)
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Blood flow in the brain will be measured during completion of two experimental tasks using functional magnetic resonance imaging (fMRI). Blood flow in the brain can be used to measure what brain areas are being activated during the performance of a task. |
During Session (Approx. 45 minutes)
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Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 00106843
- 1K23MH123931-01A1 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Objective data will be archived in raw format on the NITRIC Data Repository. Sufficient description of tasks and event markers will be included to allow reprocessing and replication by trained researchers. Original, albeit cleaned and de-identified, self-report data will also be included. Cleaning will entail the most basic review of each variable to assure correct coding, and, in justified cases, invert variable scores to make variables easier to interpret. Inversions will always be noted.
DATA FORMAT: Objective data will be delivered to NITRIC in NIFTII format for fMRI data and tab-delimited text files for EEG and physiology data. Self-report data will be delivered in SPSS .sav format. No identifying information will be included.
VARIABLE CREATION: All variable computation, weighting, and imputation syntax will be in SPSS format and delivered in .txt file. A variable definition list / codebook will also be delivered.
IPD-tijdsbestek voor delen
Immediately following publication of primary project manuscript, or by 6 months after study completion, whichever is earlier.
IPD-toegangscriteria voor delen
De-identified data will be made available through upload to the NITRIC Data Repository. As such, de-identified data will be publically available.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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