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Effects of Noninvasive Brain Stimulation on Brain Activity and Appetite

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ClinicalTrials.gov Identifier: NCT02758262
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Laval University

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.

Condition or disease Intervention/treatment Phase
Hyperphagia Device: Noninvasive brain stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : April 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Noninvasive brain stimulation: active
In active condition, subject will receive stimulation during all the duration of the experimental session.
Device: Noninvasive brain stimulation
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.
Device: Noninvasive brain stimulation



Primary Outcome Measures :
  1. Food craving assessed by the Food Cravings Questionnaire - State [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. Brain activity assessed by electroencephalography [ Time Frame: 1 hour ]
  2. Brain activity assessed by blood-oxygen-level dependent contrast imaging [ Time Frame: 1 hour ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hyperphagic

Exclusion Criteria:

  • Psychiatric disorders
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758262


Contacts
Contact: Christophe Lenglos, PhD 418-953-9586 christophe.lenglos.1@ulaval.ca

Locations
Canada
Centre interdisciplinaire de recherche en réadaptation et intégration sociale Recruiting
Quebec, Canada, G1M 2S8
Contact: Christophe Lenglos, PhD    418-953-9586    christophe.lenglos.1@ulaval.ca   
Sponsors and Collaborators
Laval University

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT02758262     History of Changes
Other Study ID Numbers: 2016-478
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Intellectual Disability
Hyperphagia
Prader-Willi Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders