NCT02927002

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

2.2 years

First QC Date

May 17, 2016

Last Update Submit

October 6, 2017

Conditions

Impulse Control Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in decision-making from pre to post stimulation assessed with the Balloon Analogue Risk Task

    10 minutes before and immediately after the 30 minutes of non invasive brain stimulation

Secondary Outcomes (3)

  • Changes in brain activity assessed between before and during stimulation measured with functional magnetic resonance (fMRI)

    20 minutes before and immediately after the 30 minutes of non invasive brain stimulation

  • Neural metabolites concentrations measured with magnetic resonance spectroscopy (MRS)

    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

    7 minutes before and 3 minutes after the end of the 30 minutes of non invasive brain stimulation

Study Arms (2)

Noninvasive brain stimulation: active

ACTIVE COMPARATOR

In active condition, subject will receive stimulation during all the 30-minute stimulation period

Device: Noninvasive brain stimulation

Noninvasive brain: sham

SHAM COMPARATOR

In sham condition, subject will receive stimulation only at the beginning and at the end of 30-minute stimulation period.

Device: Noninvasive brain stimulation

Interventions

Noninvasive brain stimulationDEVICE
Noninvasive brain stimulation: activeNoninvasive brain: sham

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Impulse control disorders according to DSM-IV criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Interdisciplinaire de Recherche en Réadaptation et Intégration

Québec, Quebec, G1M2S8, Canada

Location

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

October 6, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

October 9, 2017

Record last verified: 2017-10

Locations

CA(1)