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tDCS Applied to the OFC: Effects on Decision-Making and Impulse Control

Primary Purpose

Impulsive Behavior, Suicidal Impulses

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation

About this trial

This is an interventional basic science trial for Impulsive Behavior focused on measuring Decision-making, Impulse control, Transcranial direct current stimulation, Brain stimulation, Neuromodulation, tDCS, Iowa Gambling Task, Stroop Word-Color Task

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men or women aged 18 to 60 years

Exclusion Criteria:

Presence any psychiatric and/or neurological illness
Psychoactive substance abuse/dependence in the past 6 months
Current use of medication(s) that might influence cognition and/or affective status
Presence of an uncontrolled medical disease (e.g., cardiovascular, renal)
Pregnancy and/or lactation
Specific contraindication for tDCS (e.g., metallic head implant).

Sites / Locations

Neuromodulation Research Clinic, Douglas Mental Health University Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

Left OFC Group

Right OFC Group

Sham tDCS

Arm Description

Anode applied to the left OFC and cathode applied to the right OFC

Anode applied to the right OFC and cathode applied to the left OFC

Outcomes

Primary Outcome Measures

Change in the net score of the Iowa Gambling Task

Secondary Outcome Measures

Change in the "average-adjusted number of pumps" in the Balloon Analog Risk Task

Change in the number of risky choices in the Game of Dice Task

Change in the number of commission errors in the Continuous Performance Task

Change in the interference index in the Stroop Color-Word Test

Change in the stop-signal reaction time in the Stop-Signal Task

Full Information

NCT ID

NCT01805401

First Posted

January 16, 2013

Last Updated

October 2, 2014

Sponsor

Douglas Mental Health University Institute

1. Study Identification

Unique Protocol Identification Number

NCT01805401

Brief Title

tDCS Applied to the OFC: Effects on Decision-Making and Impulse Control

Official Title

Modulating Decision-Making and Impulse Control With Transcranial Direct Current Stimulation (tDCS) Over the Orbitofrontal Cortex (OFC): A Randomized and Sham-Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Douglas Mental Health University Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In this study the investigators aim to assess whether transcranial direct current stimulation (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and impulse control in healthy participants.

Detailed Description

In this single-blind, three-arm and sham-controlled study, we will assess whether transcranial direct current stimulation (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and impulse control in healthy volunteers. We hypothesize that tDCS applied to the OFC, in comparison to sham tDCS, will significantly enhance decision-making and impulse control. For this study we will enroll 45 healthy individuals aged 18-60 years. These individuals will be assessed with a battery of computerized tasks as well as clinician-administered and self-reported questionnaires on depression and anxiety. Assessments will be carried out before and after a single 30-minute tDCS session.

6. Conditions and Keywords

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

Impulsive Behavior, Suicidal Impulses

Keywords

Decision-making, Impulse control, Transcranial direct current stimulation, Brain stimulation, Neuromodulation, tDCS, Iowa Gambling Task, Stroop Word-Color Task

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Left OFC Group

Arm Type

Experimental

Arm Description

Anode applied to the left OFC and cathode applied to the right OFC

Arm Title

Right OFC Group

Arm Type

Experimental

Arm Description

Anode applied to the right OFC and cathode applied to the left OFC

Arm Title

Sham tDCS

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation

Other Intervention Name(s)

tDCS, Brain Polarization

Intervention Description

Anode placed over the OFC or the DLPFC and cathode placed over the occipital region

Primary Outcome Measure Information:

Title

Change in the net score of the Iowa Gambling Task

Time Frame