N/A
N=64
Modulating Impulsivity in Suicidal Adolescents With Transcranial Direct Current Stimulation (tDCS)
Impulsive Behavior
Bottom Line
View on ClinicalTrials.gov: NCT03365102 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Stop Signal Task (SST) — 255; 215; 297 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- anodal tDCS over the rIFG, (Device); anodal tDCS over the lOFC, (Device); sham tDCS stimulation condition (Device)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Lifespan
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stop Signal Task (SST) |
255; 215; 297 | — |
| PRIMARY Delay Discounting Task |
.53; .4; .57 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03365102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.