Clinical trial NCT03365102: Modulating Impulsivity in Suicidal Adolescents With Transcranial Direct Current Stimulation (tDCS)
Official title: Modulating Impulsivity in Suicidal Adolescents With tDCS: A Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impulsive Behavior
Lead sponsor: Lifespan
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 64
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: anodal tDCS over the rIFG, anodal tDCS over the lOFC, sham stimulation condition
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Stop Signal Task (SST)
timeFrame: Within an hour post-stimulation condition
measure: Delay Discounting Task
timeFrame: Within an hour post-stimulation condition
Secondary outcomes:
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Bradley Hospital
state: Rhode Island
Study officials:
affiliation: Lifespan
name: Richard Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: