search
Back to results

fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating (Cemov)

Primary Purpose

Hyperphagia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neurofeedback with functional near infra-red spectroscopy
Sham Neurofeedback
oral microbiota collection
Questionnaires
resting-state fMRI
Electro gastrogram
Emotional Stroop task
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperphagia focused on measuring emotional overeating, functional near infraRed spectroscopy, neurofeedback, cognitive control

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Eligibility

Study A :

  • Minimum age : 18 Years
  • Maximum Age : 50 Years
  • Sex : women or men

Inclusion Criteria :

  • Normal Body Mass Index (18-25),
  • Right-handlers
  • Affiliated to a social security scheme
  • Having given a free, informed and written consent

Exclusion Criteria :

Related to the study - Insufficient command of French

Related to Magnetic Resonance Imagine

  • Implantable cardiac pacemaker or defibrillator;
  • Neurosurgical clips;
  • Cochlear implants;
  • Neural or peripheral stimulator;
  • Foreign orbital or brain metallic foreign bodies;
  • Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks;
  • Claustrophobia. Related to near infra Red spectroscopy
  • Hairs that do not allow proper near infra Red spectroscopy measurement upon ligh blockage

Study B

  • Minimum age : 18 Years
  • Maximum Age : 25 Years
  • Sex : women

Inclusion Criteria :

  • Normal BMI (18-25),
  • Right-handlers
  • Affiliated to a social security scheme
  • Having given a free, informed and written consent
  • Based on emotional overeating questionary : having emotional overeating episodes > 6 days in a month for at least one negative emotion

Exclusion Criteria :

Related to the study

  • Insufficient command of French
  • Excessive consumption of alcohol or other psychoactive substances (determined on the basis of the Alcohol Use Disorders Identification Test questionnaires - excluded if score > 12 and "Car, Relax, Alone, Forget, Friends, Trouble" questionnaire - excluded if score> 1 " yes ")
  • Eating disorders ("sick, control, one stone, fat, food" questionnaire >2)
  • Food addiction (Yale Food Addiction Score 2.0, score >2
  • With psychoactive treatment
  • Digestive or gastric disorders

Related to magnetic resonance imaging

  • Implantable cardiac pacemaker or defibrillator;
  • Neurosurgical clips;
  • Cochlear implants;
  • Neural or peripheral stimulator;
  • Foreign orbital or brain metallic foreign bodies;
  • Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks;
  • Claustrophobia.

Related to near infraRed spectroscopy

- Hairs that do not allow proper near infraRed spectroscopy measurement upon ligh blockage

Sites / Locations

  • Chu Rennes - PontchaillouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Sham Comparator

Arm Label

Study A

Study B - Neurofeedback

Study B - Control

Arm Description

Validation of the reward system-related fMRI task, as determined by an increased activation on the brain reward structure (striatum) under the task.

The neurofeedback protocol will be the same during the 8 sessions constituting the protocol and taking place over a period of 4 weeks (2 neurofeedback sessions per week, the first and the last one in an MRI context). It will last 15 minutes per session, and during each session, the volunteer will have to increase the brain activity of his/her dlPFC using a visual gauge representing the "activity level" of his/her own dlPFC. No specific instructions will be given to the volunteer so that he/she can develop his/her own internal strategy to increase this "activity level".

In the control group with neurofeedback sham, the participants will receive the same instruction but will be shown a random signal, the goal being that the control strategy the participant tries to implement is not correlated with the visual feedback provided by the gauge.

Outcomes

Primary Outcome Measures

Change in cortico-striatal connectivity
Significant change in cortico-striatal connectivity as determined with resting state functional magnetic resonance imaging correlation coefficient between the first magnetic resonance imaging and the last magnetic resonance imaging visit

Secondary Outcome Measures

Full Information

First Posted
January 6, 2022
Last Updated
March 28, 2023
Sponsor
Rennes University Hospital
Collaborators
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
search

1. Study Identification

Unique Protocol Identification Number
NCT05200182
Brief Title
fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating
Acronym
Cemov
Official Title
fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Emotional overeating is characterized by an excessive food intake in the context of intense emotional situations, such as acute stress one. Emotional overeating, as a behavioral trait, can increase the risk of to develop eating disorders or eating-related diseases, such as metabolic syndrome, obesity, type-2 diabetes. Recently, imaging modalities, such as magnetic resonance imaging (MRI) and electro-encephalography (EEG), have been adapted in order to perform neurofeedback consisting on presenting the brain activity instantaneously to the participant, that give him the possibility to modify this activity by his own mean. Neurofeedback has already shown some efficacy, either with explicit or implicit instruction. Compared with functional MRI (fMRI), functional near infra-red spectroscopy (fNIRS) is easy to handle, less expensive, and does not require a lying position. fNIRS is consequently more adapted for repeated acquisitions. Neurofeedback has already shown some promising results for neurological and psychiatric diseases. For mental states and emotion regulation, neurofeedback targeting the prefrontal cortex (PFC) has also shown promising outcomes. In this project, the investigators want to assess the effect of neurofeedback targeting the dorsolateral PFC (dlPFC) in a population of young adult women presenting emotional overeating. The investigators aim to improve the cognitive control and to reduce the episodes of emotional overeating in order to prevent the occurrence of subsequent pathologies. The intervention effect will be characterized with: (i) fMRI in order to evaluate the effect on cognitive control (with resting state fMRI or rsMRI) and on the reward system; (II) questionaries directly and one month after intervention in order to assess the behavioral effect. Besides an expected effect on emotional overeating, the investigators will evaluate whether an improvement of cognitive control can also promote positive effect on other behavioral traits that could lead to some pathologies such as food addiction. As a prerequisite to this study on emotional overeating (study B), the investigators will firstly validate on healthy subjects (study A) a reward anticipation fMRI task, which will be further used in study A in order to characterized the effect of neurofeedback on the reward system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphagia
Keywords
emotional overeating, functional near infraRed spectroscopy, neurofeedback, cognitive control

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study A
Arm Type
Other
Arm Description
Validation of the reward system-related fMRI task, as determined by an increased activation on the brain reward structure (striatum) under the task.
Arm Title
Study B - Neurofeedback
Arm Type
Experimental
Arm Description
The neurofeedback protocol will be the same during the 8 sessions constituting the protocol and taking place over a period of 4 weeks (2 neurofeedback sessions per week, the first and the last one in an MRI context). It will last 15 minutes per session, and during each session, the volunteer will have to increase the brain activity of his/her dlPFC using a visual gauge representing the "activity level" of his/her own dlPFC. No specific instructions will be given to the volunteer so that he/she can develop his/her own internal strategy to increase this "activity level".
Arm Title
Study B - Control
Arm Type
Sham Comparator
Arm Description
In the control group with neurofeedback sham, the participants will receive the same instruction but will be shown a random signal, the goal being that the control strategy the participant tries to implement is not correlated with the visual feedback provided by the gauge.
Intervention Type
Device
Intervention Name(s)
Neurofeedback with functional near infra-red spectroscopy
Intervention Description
the neurofeedback protocol will last 15 minutes per session, and during each session, the volunteer will have to increase the brain activity of his/her dorsolateral prefrontal cortex using a visual gauge representing the "activity level" of his/her own dorsolateral prefrontal cortex. No specific instructions will be given to the volunteer so that he/she can develop his/her own internal strategy to increase this "activity level".
Intervention Type
Device
Intervention Name(s)
Sham Neurofeedback
Intervention Description
the participants will receive the same instruction but will be shown a random signal
Intervention Type
Other
Intervention Name(s)
oral microbiota collection
Intervention Description
an examination and oral swab for oral microbiota analysis will be performed by a dentist
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
questionnaires for pre-intervention behavioral characterization
Intervention Type
Device
Intervention Name(s)
resting-state fMRI
Intervention Description
characterize the brain function of volunteers by resting-state fMRI
Intervention Type
Device
Intervention Name(s)
Electro gastrogram
Intervention Description
Volunteers will also be equipped with an MRI-compatible electro-gastrogram device to correlate gastric signals with brain activity during rsMRI acquisition.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Stroop task
Intervention Description
an emotional Stroop task adapted to food and body image representation
Primary Outcome Measure Information:
Title
Change in cortico-striatal connectivity
Description
Significant change in cortico-striatal connectivity as determined with resting state functional magnetic resonance imaging correlation coefficient between the first magnetic resonance imaging and the last magnetic resonance imaging visit
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Eligibility Study A : Minimum age : 18 Years Maximum Age : 50 Years Sex : women or men Inclusion Criteria : Normal Body Mass Index (18.5-25), Right-handlers Affiliated to a social security scheme Having given a free, informed and written consent Exclusion Criteria : Related to the study - Insufficient command of French Related to Magnetic Resonance Imagine Implantable cardiac pacemaker or defibrillator; Neurosurgical clips; Cochlear implants; Neural or peripheral stimulator; Foreign orbital or brain metallic foreign bodies; Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks; Claustrophobia. Related to near infra Red spectroscopy Hairs that do not allow proper near infra Red spectroscopy measurement upon ligh blockage Study B Minimum age : 18 Years Maximum Age : 25 Years Sex : women Inclusion Criteria : Normal BMI (18.5-25), Right-handlers Affiliated to a social security scheme Having given a free, informed and written consent Based on emotional overeating questionary : having emotional overeating episodes > 6 days in a month for at least one negative emotion Exclusion Criteria : Related to the study Insufficient command of French Excessive consumption of alcohol or other psychoactive substances (determined on the basis of the Alcohol Use Disorders Identification Test questionnaires - excluded if score > 12 and "Car, Relax, Alone, Forget, Friends, Trouble" questionnaire - excluded if score> 1 " yes ") Eating disorders ("sick, control, one stone, fat, food" questionnaire >2) Food addiction (Yale Food Addiction Score 2.0, score >2 With psychoactive treatment Digestive or gastric disorders Related to magnetic resonance imaging Implantable cardiac pacemaker or defibrillator; Neurosurgical clips; Cochlear implants; Neural or peripheral stimulator; Foreign orbital or brain metallic foreign bodies; Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks; Claustrophobia. Related to near infraRed spectroscopy - Hairs that do not allow proper near infraRed spectroscopy measurement upon ligh blockage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loïc JACOB
Phone
0299282555
Email
loic.jacob@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas COQUERY, PhD
Email
nicolas.coquery@inrae.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain Moirand, MD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Rennes - Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain Moirand, MD
Email
romain.moirand@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Nicolas COQUERY
Email
nicolas.coquery@inrae.fr
First Name & Middle Initial & Last Name & Degree
Romain Moirand, MD

12. IPD Sharing Statement

Learn more about this trial

fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating

We'll reach out to this number within 24 hrs