Back to resultsEffects of Non-invasive Brain Stimulation in Impulse Control Disorders
Primary Purpose
Impulse Control Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Noninvasive brain stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Impulse Control Disorder
Eligibility Criteria
Inclusion Criteria:
- Impulse control disorders according to DSM-IV criteria
Exclusion Criteria:
- Other psychiatric disorders
- Contraindication to Non-invasive brain stimulation and MRI
Sites / Locations
- Centre Interdisciplinaire de Recherche en Réadaptation et Intégration
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Noninvasive brain stimulation: active
Noninvasive brain: sham
Arm Description
In active condition, subject will receive stimulation during all the 30-minute stimulation period
In sham condition, subject will receive stimulation only at the beginning and at the end of 30-minute stimulation period.
Outcomes
Primary Outcome Measures
Change in decision-making from pre to post stimulation assessed with the Balloon Analogue Risk Task
Secondary Outcome Measures
Changes in brain activity assessed between before and during stimulation measured with functional magnetic resonance (fMRI)
Neural metabolites concentrations measured with magnetic resonance spectroscopy (MRS)
Change in Craving from pre to post stimulation assessed with a single standardized scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02927002
Brief Title
Effects of Non-invasive Brain Stimulation in Impulse Control Disorders
Official Title
Effects of Non-invasive Brain on Decision-making in Impulse Control Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulse Control Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Noninvasive brain stimulation: active
Arm Type
Active Comparator
Arm Description
In active condition, subject will receive stimulation during all the 30-minute stimulation period
Arm Title
Noninvasive brain: sham
Arm Type
Sham Comparator
Arm Description
In sham condition, subject will receive stimulation only at the beginning and at the end of 30-minute stimulation period.
Intervention Type
Device
Intervention Name(s)
Noninvasive brain stimulation
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Impulse control disorders according to DSM-IV criteria
Exclusion Criteria:
Other psychiatric disorders
Contraindication to Non-invasive brain stimulation and MRI
Facility Information:
Facility Name
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1M2S8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Non-invasive Brain Stimulation in Impulse Control Disorders
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