HyperphagiaNCT02758262
Effects of Noninvasive Brain Stimulation on Brain Activity and Appetite
A study testing Noninvasive brain stimulation in people with Hyperphagia, run by Laval University at 1 site in Canada.
Trial summary
The goal of this project is to identify brain mechanisms by which Noninvasive brain stimulation (NIBS) could decrease hyperphagia. The investigators will synchronously deliver NIBS and measure brain activity in a randomized, crossover, sham-controlled, fully blind study. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Hyperphagia
- 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
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Dec 2017
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hyperphagic
Who cannot join
- Psychiatric disorders
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre interdisciplinaire de recherche en réadaptation et intégration sociale
Québec, Quebec, G1M 2S8
Christophe Lenglos, PhD, 418-953-9586, christophe.lenglos.1@ulaval.ca
About this study
The goal of this project is to identify brain mechanisms by which Noninvasive brain stimulation (NIBS) could decrease hyperphagia. The investigators will synchronously deliver NIBS and measure brain activity in a randomized, crossover, sham-controlled, fully blind study. This work will reveal brain mechanisms to reduce hyperphagia and may contribute to new therapeutic avenues to treat this eating disorder.
- Conditions
- Hyperphagia
- Being tested
- Noninvasive brain stimulation
- Medical subject headings
- Hyperphagia
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 duration of the experimental session. Receives: Device: Noninvasive brain stimulation |
| Noninvasive brain stimulation: sham | Placebo comparator | In sham condition, subject will receive stimulation only at the beginning and at the end of the experimental session. Receives: Device: Noninvasive brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food craving assessed by the Food Cravings Questionnaire - State
Measured: 1 hour
Secondary outcomes (2)
Brain activity assessed by electroencephalography
Measured: 1 hour
Brain activity assessed by blood-oxygen-level dependent contrast imaging
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphagiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758262
- Sponsor's protocol ID
- 2016-478
- Status last verified
- Mar 2017
- First submitted
- 26 Apr 2016
- Last updated
- 4 Apr 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 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Noninvasive Brain Stimulation on Brain Activity and Appetite
- ClinicalTrials.gov ID
- NCT02758262
- Acronym / sponsor ID
- 2016-478
- Conditions
- Hyperphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 May 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 identify brain mechanisms by which Noninvasive brain stimulation (NIBS) could decrease hyperphagia. The investigators will synchronously deliver NIBS and measure brain activity in a randomized, crossover, sham-controlled, fully blind study. This work will reveal brain mechanisms to reduce hyperphagia and may contribute to new therapeutic avenues to treat this eating disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- 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 duration of the experimental session. |
| Noninvasive brain stimulation: sham | Placebo comparator | Device: Noninvasive brain stimulationIn sham condition, subject will receive stimulation only at the beginning and at the end of the experimental session. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Hyperphagic
Key exclusion criteria (2 listed)
- Psychiatric disorders
- Pregnancy
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 stimulation: sham |
Primary outcome
Food craving assessed by the Food Cravings Questionnaire - State
Time frame: 1 hour
2 secondary outcomes
Brain activity assessed by electroencephalography
Time frame: 1 hour
Brain activity assessed by blood-oxygen-level dependent contrast imaging
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 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.
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 Hyperphagia, 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 4 Apr 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?
Contact Christophe Lenglos, PhD (418-953-9586, christophe.lenglos.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food craving assessed by the Food Cravings Questionnaire - State (time frame: 1 hour). 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 4 Apr 2017.