Effects of Noninvasive Brain Stimulation on Brain Activit... | NCT02758262

Studies
Effects of Noninvasive Brain Stimulation on Brain Activity and Appetite

NCT02758262

Sponsor

Laval University

Status

Unknown status

Last Update Posted

Apr 4, 2017Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Hyperphagia

Interventions

Noninvasive brain stimulation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Aug 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Apr 26, 2016

First Submission Date that Met QC Criteria

Apr 28, 2016

First Posted Date

May 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2017

Last Update Posted Date

Apr 4, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Noninvasive brain stimulation	Device		Noninvasive brain stimulation: active Noninvasive brain stimulation: sham

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Food craving assessed by the Food Cravings Questionnaire - State		1 hour

Secondary Outcomes

Measure	Description	Time Frame
Brain activity assessed by electroencephalography		1 hour
Brain activity assessed by blood-oxygen-level dependent contrast imaging		1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hyperphagic

Exclusion Criteria:

Psychiatric disorders
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christophe Lenglos, PhD	Contact	418-953-9586		christophe.lenglos.1@ulaval.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre interdisciplinaire de recherche en réadaptation et intégration sociale	Recruiting	Québec	Quebec	G1M 2S8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006963	Hyperphagia

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided