Back to resultsEffects of Noninvasive Brain Stimulation on Brain Activity and Appetite
Primary Purpose
Hyperphagia
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 Hyperphagia
Eligibility Criteria
Inclusion Criteria:
- Hyperphagic
Exclusion Criteria:
- Psychiatric disorders
- Pregnancy
Sites / Locations
- Centre interdisciplinaire de recherche en réadaptation et intégration socialeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Noninvasive brain stimulation: active
Noninvasive brain stimulation: sham
Arm Description
In active condition, subject will receive stimulation during all the duration of the experimental session.
In sham condition, subject will receive stimulation only at the beginning and at the end of the experimental session.
Outcomes
Primary Outcome Measures
Food craving assessed by the Food Cravings Questionnaire - State
Secondary Outcome Measures
Brain activity assessed by electroencephalography
Brain activity assessed by blood-oxygen-level dependent contrast imaging
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02758262
Brief Title
Effects of Noninvasive Brain Stimulation on Brain Activity and Appetite
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
December 2017 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphagia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
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 duration of the experimental session.
Arm Title
Noninvasive brain stimulation: sham
Arm Type
Placebo Comparator
Arm Description
In sham condition, subject will receive stimulation only at the beginning and at the end of the experimental session.
Intervention Type
Device
Intervention Name(s)
Noninvasive brain stimulation
Primary Outcome Measure Information:
Title
Food craving assessed by the Food Cravings Questionnaire - State
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Brain activity assessed by electroencephalography
Time Frame
1 hour
Title
Brain activity assessed by blood-oxygen-level dependent contrast imaging
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hyperphagic
Exclusion Criteria:
Psychiatric disorders
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Lenglos, PhD
Phone
418-953-9586
Email
christophe.lenglos.1@ulaval.ca
Facility Information:
Facility Name
Centre interdisciplinaire de recherche en réadaptation et intégration sociale
City
Quebec
ZIP/Postal Code
G1M 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Lenglos, PhD
Phone
418-953-9586
Email
christophe.lenglos.1@ulaval.ca
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Noninvasive Brain Stimulation on Brain Activity and Appetite
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