NCT02758262

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

April 26, 2016

Last Update Submit

March 31, 2017

Conditions

Hyperphagia

Outcome Measures

Primary Outcomes (1)

  • Food craving assessed by the Food Cravings Questionnaire - State

    1 hour

Secondary Outcomes (2)

  • Brain activity assessed by electroencephalography

    1 hour

  • Brain activity assessed by blood-oxygen-level dependent contrast imaging

    1 hour

Study Arms (2)

Noninvasive brain stimulation: active

ACTIVE COMPARATOR

In active condition, subject will receive stimulation during all the duration of the experimental session.

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.

Device: Noninvasive brain stimulation

Interventions

Noninvasive brain stimulationDEVICE
Noninvasive brain stimulation: activeNoninvasive brain stimulation: sham

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hyperphagic

You may not qualify if:

  • Psychiatric disorders
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre interdisciplinaire de recherche en réadaptation et intégration sociale

Québec, Quebec, G1M 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Christophe Lenglos, PhD

CONTACT

418-953-9586christophe.lenglos.1@ulaval.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2016

First Posted

May 2, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

CA(1)