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

NCT03365102 | Completed Results DMC FDA Device

• 1 other identifier: Liu 002017
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Impulsive Behavior

Outcome Measures

Primary Outcomes (2)

• Stop Signal Task (SST)

  The Stop-Signal Task (SST) is a task requiring inhibition of a prepotent motor response. The SST requires participants to respond to a target stimulus as quickly and accurately as possible by pressing a button, but also to withhold their response when they hear an auditory signal. Thus, this task involves a competition between activating and inhibiting processes. The primary outcome variable is change in the stop signal reaction time (SSRT) for the task administered seconds to minutes before and seconds to minutes after stimulation. The theoretical minimum is zero seconds and there is no theoretical maximum. Higher SSRT scores reflect greater impulsivity.

  Within an hour post-stimulation condition

• Delay Discounting Task

  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.

  Within an hour post-stimulation condition

Study Arms (3)

anodal tDCS over the rIFG,

EXPERIMENTAL

anodal tDCS over the rIFG,

Device: anodal tDCS over the rIFG,

anodal tDCS over the lOFC

EXPERIMENTAL

anodal tDCS over the lOFC

Device: anodal tDCS over the lOFC,

sham tDCS stimulation

PLACEBO COMPARATOR

sham tDCS stimulation

Device: sham tDCS stimulation condition

Interventions

anodal tDCS over the rIFG, DEVICE

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.

anodal tDCS over the rIFG,

anodal tDCS over the lOFC, DEVICE

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.

anodal tDCS over the lOFC

sham tDCS stimulation condition DEVICE

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.

sham tDCS stimulation

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lifespan: lead

Study Sites (1)

Bradley Hospital

Riverside, Rhode Island, 02915, United States

Location

MeSH Terms

Conditions

Impulsive Behavior

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Multiple and persistent technical problems were experienced with the device used in this study. It was not possible to confirm that stimulation reliably occurred and that therefore all study participants received then intended stimulation. Caution should therefore be taken in interpreting the results of this study.

Results Point of Contact

• Title: Richard Jones
• Organization: Brown University

rich_jones@brown.edu

401-444-1943

Study Officials

• Richard Liu, PhD

  Lifespan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Neither participant or outcome aware of condition
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: anodal tDCS over the rIFG, anodal tDCS over the lOFC, sham stimulation condition

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: December 7, 2017
• Study Start: April 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 2, 2022
• Results First Posted: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: April 1, 2021
• Access Criteria: 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.

Locations

US (1)