Modulating Impulsivity in Suicidal Adolescents With Transcranial Direct Current Stimulation (tDCS) (tDCS)
5 januari 2022 bijgewerkt door: Richard Liu, Lifespan
Modulating Impulsivity in Suicidal Adolescents With tDCS: A Proof of Concept Study
As a first step toward investigating whether modulation of impulsivity and associated neural pathways may yield clinically meaningful changes in risk for adolescent suicidal behavior, the R21 is a proof-of concept study evaluating the potential for tDCS targeting brain regions associated with behavioral impulsivity (right inferior frontal gyrus [rIFG]) and cognitive impulsivity (left orbitofrontal cortex [lOFC]) to modulate these facets of impulsivity in a sample of adolescent suicide attempters.
Participants will be randomly assigned to receive anodal tDCS over the rIFG, anodal tDCS over the lOFC, or a sham stimulation condition, in a three-group design.
Task-based measures of behavioral and cognitive impulsivity will be administered before and after tDCS or sham stimulation.
Additionally, electroencephalography (EEG) and event-related potential (ERP) data will be collected during the impulsivity tasks, and resting-state EEG data will be collected pre- and post-tDCS administration to confirm engagement of the targeted brain regions and to delineating the neural pathways underlying the effects of tDCS on impulsivity.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
Suicide is one of the leading causes of death in adolescence.
To improve the ability to predict and prevent suicidal behavior, there is a pressing need for research in this area to advance beyond identifying risk factors toward a greater focus on the mechanisms of risk for this behavior.
In particular, elucidating the neural pathways underlying risk for suicidal behavior is important insofar as such work may yield specific and modifiable targets for clinical intervention.
The adoption of new experimental paradigms providing experimental control over potentially modifiable risk factors has been recommended as a means of meaningfully advancing the field in this regard.
Although yet to be applied to the study of suicidality, transcranial direct current stimulation (tDCS), in conjunction with measures of electroencephalography (EEG) and event-related potentials (ERPs), may hold promise as an experimental paradigm in the study of potentially modifiable risk factors, and underlying neural mechanisms, for suicidality.
One such risk factor of particular relevance to suicide in adolescence is state-sensitive aspects of impulsivity.
Impulsivity has been consistently linked with suicidality, with this association appearing to be stronger in adolescence than adulthood.
As a first step toward investigating whether modulation of impulsivity and associated neural pathways may yield clinically meaningful changes in risk for adolescent suicidal behavior, the R21 is a proof-of concept study evaluating the potential for tDCS targeting brain regions associated with behavioral impulsivity (right inferior frontal gyrus [rIFG]) and cognitive impulsivity (left orbitofrontal cortex [lOFC]) to modulate these facets of impulsivity in a sample of adolescent suicide attempters.
Participants will be randomly assigned to receive anodal tDCS over the rIFG, anodal tDCS over the lOFC, or a sham stimulation condition, in a three-group design.
Task-based measures of behavioral and cognitive impulsivity will be administered before and after tDCS or sham stimulation.
Additionally, EEG and ERP data will be collected during the impulsivity tasks, and resting-state EEG data will be collected pre- and post-tDCS administration to confirm engagement of the targeted brain regions and to delineating the neural pathways underlying the effects of tDCS on impulsivity.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
64
Fase
- 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
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Rhode Island
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Riverside, Rhode Island, Verenigde Staten, 02915
- Bradley Hospital
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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
Leeftijden die in aanmerking komen voor studie
13 jaar tot 17 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- have attempted suicide prior to admission
- speak and read English fluently
- do not display evidence of significant cognitive impairment, based on a standard psychiatric exam as well as school records on admission
- are not actively psychotic at time of intake.
Exclusion Criteria:
- a significant general medical condition
- history of seizure, head injury, brain surgery or tumor
- intracranial metallic implants or implanted electrical devices
- substance abuse or dependence in the past six months.
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: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: anodal tDCS over the rIFG,
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tDCS at a constant current of 1.5 milliampere (mA) will be applied for one 20-minute session over the right inferior frontal gyrus .
Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS.
After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure.
The participants and assessors will be blind to experimental condition.
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Experimenteel: anodal tDCS over the lOFC
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tDCS at a constant current of 1.5 mA will be applied for one 20-minute session over the left orbitofrontal cortex .
Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS.
After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure.
The participants and assessors will be blind to experimental condition.
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Placebo-vergelijker: sham tDCS stimulation
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In the sham condition, the current will be ramped up to 1.5 mA for 30 seconds and then ramped back down to 0. As this commonly used sham procedure produces a brief tingling sensation, participants are kept unaware of their experimental condition.
Resting-state EEG for 10 minutes will be recorded immediately prior to and after the sham tDCS.
After post-sham stimulation resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure.
The participants and assessors will be blind to experimental condition.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Stopsignaaltaak (SST)
Tijdsspanne: Binnen een uur na stimulatieconditie
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De Stop-Signal Task (SST) is een taak die remming van een overheersende motorische reactie vereist.
De SST vereist dat deelnemers zo snel en nauwkeurig mogelijk reageren op een doelstimulus door op een knop te drukken, maar ook hun reactie inhouden wanneer ze een auditief signaal horen.
Deze taak omvat dus een competitie tussen activerende en remmende processen.
De primaire uitkomstvariabele is verandering in de stopsignaalreactietijd (SSRT) voor de uitgevoerde taak seconden tot minuten voor en seconden tot minuten na stimulatie.
Het theoretisch minimum is nul seconden en er is geen theoretisch maximum.
Hogere SSRT-scores weerspiegelen een grotere impulsiviteit.
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Binnen een uur na stimulatieconditie
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Delay Discounting Task
Tijdsspanne: Within an hour post-stimulation condition
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This task assessed discounting larger future rewards for smaller immediate ones.
The point where a person is equally likely to prefer immediate vs delayed reward (the indifference point) is determined for several and combinations of reward sizes and lengths of time.
Area under the curve (AUC) is calculated by summing the results of the following for each delay and indifference point pair: x2-x1[(y1 + y2)/2].
x1 and x2 are successive delays and y1 and y2 are indifference points for those delays.
AUC range=0-1.
Larger AUCs reflect less impulsivity.
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Within an hour post-stimulation condition
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Richard Liu, PhD, Lifespan
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)
1 april 2017
Primaire voltooiing (Werkelijk)
31 december 2019
Studie voltooiing (Werkelijk)
31 december 2019
Studieregistratiedata
Eerst ingediend
2 augustus 2017
Eerst ingediend dat voldeed aan de QC-criteria
5 december 2017
Eerst geplaatst (Werkelijk)
7 december 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 februari 2022
Laatste update ingediend die voldeed aan QC-criteria
5 januari 2022
Laatst geverifieerd
1 januari 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Liu 002017
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Analysis files will be constructed from the stored electronic data and will be stripped of identifying information with the Safe Harbor method.
Specifically, youth and their parents will be identified with a family identifier and person identifier number that is randomly generated and not related to any element of their personal identifying information.
No names, addresses, telephone numbers, fax numbers, email addresses, social security numbers, medical records, etc. will be retained.
Dates will contain only year and a randomly generated day-of-the-year.
The investigators will only share it with external investigators when a data use agreement (DUA) is executed between Lifespan and the requester's institution.
The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project, and schedule for data destruction.
The data will be made available on April 1, 2021 by the PI
IPD-tijdsbestek voor delen
April 1, 2021
IPD-toegangscriteria voor delen
The investigators will only share it with external investigators when a data use agreement (DUA) is executed between the Brown University and the requester's institution.
The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project, and schedule for data destruction.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
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 .