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Effects of Non-invasive Brain Stimulation in Impulse Control Disorders

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ClinicalTrials.gov Identifier: NCT02927002
Recruitment Status : Active, not recruiting
First Posted : October 6, 2016
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Laval University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Impulse Control Disorder Device: Noninvasive brain stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Non-invasive Brain on Decision-making in Impulse Control Disorders
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Impulse control disorders according to DSM-IV criteria

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927002


Locations
Canada, Quebec
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration
Québec, Quebec, Canada, G1M2S8
Sponsors and Collaborators
Laval University

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT02927002     History of Changes
Other Study ID Numbers: 2014-374
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Disease
Disruptive, Impulse Control, and Conduct Disorders
Pathologic Processes
Mental Disorders