Impulse Control DisorderNCT02927002
Effects of Non-invasive Brain Stimulation in Impulse Control Disorders
A study testing Noninvasive brain stimulation in people with Impulse Control Disorder, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Impulse Control Disorder
- What is being tested?
- Noninvasive brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Impulse control disorders according to DSM-IV criteria
Who cannot join
- Other psychiatric disorders
- Contraindication to Non-invasive brain stimulation and MRI
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration
Québec, Quebec, G1M2S8
About this study
Official title: 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.
- Conditions
- Impulse Control Disorder
- Being tested
- Noninvasive brain stimulation
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive brain stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive brain stimulation: active | Active comparator | In active condition, subject will receive stimulation during all the 30-minute stimulation period Receives: 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. Receives: Device: Noninvasive brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in decision-making from pre to post stimulation assessed with the Balloon Analogue Risk Task
Measured: 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)
Measured: 20 minutes before and immediately after the 30 minutes of non invasive brain stimulation
Neural metabolites concentrations measured with magnetic resonance spectroscopy (MRS)
Measured: 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
Measured: 7 minutes before and 3 minutes after the end of the 30 minutes of non invasive brain stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impulse Control DisorderStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927002
- Sponsor's protocol ID
- 2014-374
- Status last verified
- Oct 2017
- First submitted
- 17 May 2016
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-invasive Brain on Decision-making in Impulse Control Disorders
- ClinicalTrials.gov ID
- NCT02927002
- Acronym / sponsor ID
- 2014-374
- Conditions
- Impulse Control Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive brain stimulation: active | Active comparator | Device: Noninvasive brain stimulationIn active condition, subject will receive stimulation during all the 30-minute stimulation period |
| Noninvasive brain: sham | Sham comparator | Device: Noninvasive brain stimulationIn sham condition, subject will receive stimulation only at the beginning and at the end of 30-minute stimulation period. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Impulse control disorders according to DSM-IV criteria
Key exclusion criteria (2 listed)
- Other psychiatric disorders
- Contraindication to Non-invasive brain stimulation and MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive brain stimulation | Device | Noninvasive brain stimulation: active, Noninvasive brain: sham |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive brain stimulation in people with Impulse Control Disorder, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.