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

Primary Purpose

Impulsive Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
anodal tDCS over the rIFG,
anodal tDCS over the lOFC,
sham tDCS stimulation condition
Sponsored by
Lifespan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Impulsive Behavior

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Bradley Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

anodal tDCS over the rIFG,

anodal tDCS over the lOFC

sham tDCS stimulation

Arm Description

anodal tDCS over the rIFG,

anodal tDCS over the lOFC

sham tDCS stimulation

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2017
Last Updated
January 5, 2022
Sponsor
Lifespan
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1. Study Identification

Unique Protocol Identification Number
NCT03365102
Brief Title
Modulating Impulsivity in Suicidal Adolescents With Transcranial Direct Current Stimulation (tDCS)
Acronym
tDCS
Official Title
Modulating Impulsivity in Suicidal Adolescents With tDCS: A Proof of Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lifespan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsive Behavior

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
anodal tDCS over the rIFG, anodal tDCS over the lOFC, sham stimulation condition
Masking
ParticipantOutcomes Assessor
Masking Description
Neither participant or outcome aware of condition
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anodal tDCS over the rIFG,
Arm Type
Experimental
Arm Description
anodal tDCS over the rIFG,
Arm Title
anodal tDCS over the lOFC
Arm Type
Experimental
Arm Description
anodal tDCS over the lOFC
Arm Title
sham tDCS stimulation
Arm Type
Placebo Comparator
Arm Description
sham tDCS stimulation
Intervention Type
Device
Intervention Name(s)
anodal tDCS over the rIFG,
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
anodal tDCS over the lOFC,
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham tDCS stimulation condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stop Signal Task (SST)
Description
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.
Time Frame
Within an hour post-stimulation condition
Title
Delay Discounting Task
Description
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.
Time Frame
Within an hour post-stimulation condition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Liu, PhD
Organizational Affiliation
Lifespan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bradley Hospital
City
Riverside
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
April 1, 2021
IPD Sharing 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.

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

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