Modulating Impulsivity in Suicidal Adolescents With Transcranial Direct Current Stimulation (tDCS) (tDCS)
5 januari 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
64
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Rhode Island
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Riverside, Rhode Island, Förenta staterna, 02915
- Bradley Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
13 år till 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: anodal tDCS over the lOFC
|
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.
|
|
Placebo-jämförare: sham tDCS stimulation
|
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Stoppa signaluppgift (SST)
Tidsram: Inom en timme efter stimulering
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Stop-Signal Task (SST) är en uppgift som kräver inhibering av en prepotent motorisk respons.
SST kräver att deltagarna svarar på en målstimulus så snabbt och exakt som möjligt genom att trycka på en knapp, men också att de håller tillbaka sitt svar när de hör en hörselsignal.
Denna uppgift innebär alltså en konkurrens mellan aktiverande och hämmande processer.
Den primära utfallsvariabeln är förändring av stoppsignalens reaktionstid (SSRT) för uppgiften som administreras sekunder till minuter före och sekunder till minuter efter stimulering.
Det teoretiska minimumet är noll sekunder och det finns inget teoretiskt maximum.
Högre SSRT-poäng återspeglar större impulsivitet.
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Inom en timme efter stimulering
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Delay Discounting Task
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Richard Liu, PhD, Lifespan
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2017
Primärt slutförande (Faktisk)
31 december 2019
Avslutad studie (Faktisk)
31 december 2019
Studieregistreringsdatum
Först inskickad
2 augusti 2017
Först inskickad som uppfyllde QC-kriterierna
5 december 2017
Första postat (Faktisk)
7 december 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 februari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 januari 2022
Senast verifierad
1 januari 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Liu 002017
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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
Tidsram för IPD-delning
April 1, 2021
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
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