Effects of Non-invasive Brain Stimulation in Impulse Control Disorders

October 6, 2017 updated by: Laval University

Effects of Non-invasive Brain on Decision-making in Impulse Control Disorders

The goal of this project is to study the effect of noninvasive brain stimulation on decision-making and on brain activity in impulse control disorders.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1M2S8
        • Centre Interdisciplinaire de Recherche en Réadaptation et Intégration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Impulse control disorders according to DSM-IV criteria

Exclusion Criteria:

  • Other psychiatric disorders
  • Contraindication to Non-invasive brain stimulation and MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Noninvasive brain stimulation: active
In active condition, subject will receive stimulation during all the 30-minute stimulation period
Device: Noninvasive brain stimulation
Sham Comparator: Noninvasive brain: sham
In sham condition, subject will receive stimulation only at the beginning and at the end of 30-minute stimulation period.
Device: Noninvasive brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in decision-making from pre to post stimulation assessed with the Balloon Analogue Risk Task
Time Frame: 10 minutes before and immediately after the 30 minutes of non invasive brain stimulation
10 minutes before and immediately after the 30 minutes of non invasive brain stimulation

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in brain activity assessed between before and during stimulation measured with functional magnetic resonance (fMRI)
Time Frame: 20 minutes before and immediately after the 30 minutes of non invasive brain stimulation
20 minutes before and immediately after the 30 minutes of non invasive brain stimulation
Neural metabolites concentrations measured with magnetic resonance spectroscopy (MRS)
Time Frame: 20 minutes before and immediately after the 30 minutes of non invasive brain stimulation
20 minutes before and immediately after the 30 minutes of non invasive brain stimulation
Change in Craving from pre to post stimulation assessed with a single standardized scale
Time Frame: 7 minutes before and 3 minutes after the end of the 30 minutes of non invasive brain stimulation
7 minutes before and 3 minutes after the end of the 30 minutes of non invasive brain stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 9, 2017

Last Update Submitted That Met QC Criteria

October 6, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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