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Modulating Impulsivity in Suicidal Adolescents With Transcranial Direct Current Stimulation (tDCS)

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Lifespan

Status

Completed

Conditions

Impulsive Behavior

Treatments

Device: anodal tDCS over the lOFC,
Device: anodal tDCS over the rIFG,
Device: sham tDCS stimulation condition

Study type

Interventional

Funder types

Other

Identifiers

NCT03365102
Liu 002017

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 3 patient groups, including a placebo group

anodal tDCS over the rIFG,
Experimental group
Description:
anodal tDCS over the rIFG,
Treatment:
Device: anodal tDCS over the rIFG,
anodal tDCS over the lOFC
Experimental group
Description:
anodal tDCS over the lOFC
Treatment:
Device: anodal tDCS over the lOFC,
sham tDCS stimulation
Placebo Comparator group
Description:
sham tDCS stimulation
Treatment:
Device: sham tDCS stimulation condition

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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