- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02758262
Effects of Noninvasive Brain Stimulation on Brain Activity and Appetite
March 31, 2017 updated by: Laval University
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christophe Lenglos, PhD
- Phone Number: 418-953-9586
- Email: christophe.lenglos.1@ulaval.ca
Study Locations
-
-
-
Quebec, Canada, G1M 2S8
- Recruiting
- Centre interdisciplinaire de recherche en réadaptation et intégration sociale
-
Contact:
- Christophe Lenglos, PhD
- Phone Number: 418-953-9586
- Email: christophe.lenglos.1@ulaval.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hyperphagic
Exclusion Criteria:
- Psychiatric disorders
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Noninvasive brain stimulation: active
In active condition, subject will receive stimulation during all the duration of the experimental session.
|
|
PLACEBO_COMPARATOR: Noninvasive brain stimulation: sham
In sham condition, subject will receive stimulation only at the beginning and at the end of the experimental session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Food craving assessed by the Food Cravings Questionnaire - State
Time Frame: 1 hour
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brain activity assessed by electroencephalography
Time Frame: 1 hour
|
1 hour
|
Brain activity assessed by blood-oxygen-level dependent contrast imaging
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (ANTICIPATED)
August 1, 2017
Study Completion (ANTICIPATED)
December 1, 2017
Study Registration Dates
First Submitted
April 26, 2016
First Submitted That Met QC Criteria
April 28, 2016
First Posted (ESTIMATE)
May 2, 2016
Study Record Updates
Last Update Posted (ACTUAL)
April 4, 2017
Last Update Submitted That Met QC Criteria
March 31, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-478
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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