Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects. (CaDOb)
Primary Purpose
Obesity, Craving
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sham
NF
Sponsored by
About this trial
This is an interventional other trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Eligible for obesity surgery according to the 2009 French High Authority on Health (HAS) criteria (BMI ≥40 or BMI ≥35 with comorbidities)
- Presenting a food addiction determined by the YFAS 2.0 questionnaire ;
- Affiliated to a social security system;
- Having given free and informed consent in writing.
Exclusion Criteria:
- Psychotic psychiatric disorders (schizophrenic disorders and bipolar disorders);
- Psychotropic treatments;
- Addiction to alcohol or other psychoactive substances (except tobacco);
- History of bariatric surgery;
- Current treatment in the nutrition unit;
- Insufficient command of French;
- Pregnant or breast-feeding woman;
- Persons of legal age under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
- Contraindications to fMRI
- Inability to perform the fNIRS procedure due to blockage or attenuation of the light at the capillary level
Sites / Locations
- CHU RennesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
NF
Sham
Arm Description
Outcomes
Primary Outcome Measures
Number of patients who have a difference in resting state IRM after NF session
Difference in resting state IRM at inclusion and at 1 month after the 8th NF session between sham and experimental.
Resting state IRM will allow to determine the correlation coefficient of the IRM BOLD signal fluctuations between the dlPFC and the striatum. The evolution of cognitive control by NeuroFeedback (NF) will thus be determined by a variation of this correlation coefficient and thus of the cortico-striatal connectivity at inclusion and after the 8th NF session.
Secondary Outcome Measures
Number of patients who have a difference in resting state IRM after NF training in the cognitive food anticipation task condition
Variation in hemodynamic BOLD response in the cognitive food anticipation task condition between V1 and V8 between groups (NF vs sham).
Difference in resting state IRM at inclusion and at 1 month after the 8th NF session between sham and experimental.
Resting state IRM will allow to determine the correlation coefficient of the IRM BOLD signal fluctuations between the dlPFC and the striatum. The evolution of cognitive control by NeuroFeedback (NF) will thus be determined by a variation of this correlation coefficient and thus of the cortico-striatal connectivity at inclusion and after the 8th NF session.
Difference in blood pressure status 3 months after NF training
Evolution of health status using blood pressure (mmHg) between groups (NF vs sham) before and after participation (between V0 and V9).
Difference in blood pressure status 3 months after NF training
Evolution of health status using clinical exam criteria between groups (NF vs sham) before and after participation (between V0 and V9).
Difference in biological check up 3 months after NF training
Evolution of health status using biological check up between groups (NF vs sham) before and after participation (between V0 and V9).
Change of degree of correlation between EGG results and resting state IRM after NF training
Variation in the degree of correlation between electrogastrogramm plots and resting state MRI between V1 and V8 and between groups (NF vs sham).
Difference in mental Heath status after NF training between groups
Difference in anxiety and depression questionnaire (Hospital Anxiety and Depression Scale, questionnaire with 2 subscores, one for anxiety and one for depression. 0 = no anxiety/depression, 11 and more : anxiety/depression) after NF training between groups
Difference in mental Heath status training between groups after 3 months
Difference in anxiety and depression questionnaire (Hospital Anxiety and Depression Scale, questionnaire with 2 subscores, one for anxiety and one for depression. 0 = no anxiety/depression, 11 and more : anxiety/depression) 3 months after NF training between groups
Difference in Food frequency questionnaire scores between groups after NF training
Variation in FF questionnaire scores as a function of NF effect from inclusion to end of intervention.
Food frequency questionnaire (FFQ) is a dietary assessment tool delivered as a questionnaire to estimate frequency and, in some cases, portion size information about food and beverage consumption over a specified period of time
Difference in Food Cravings Questionnaire-Trait-reduced scores between groups after NF training
Variation in Food Cravings Questionnaire-Trait-reduced scores as a function of NF effect from inclusion to end of intervention.
Food Cravings Questionnaire (FCQ), which consists of a trait (FCQ-T; 39 items) and state (FCQ-S; 15 items) version. FCQ-T-r is a self-administrated questionnaire consisted of 15-items scored using a Likert-type scale (1 = never, 2 = rarely, 3 = sometimes, 4 = usually, 6 = always), for possible total scores ranging from 15 to 90.
Difference in Food Cravings Questionnaire-Trait-reduced scores between groups 3 months after NF training
Variation in Food Cravings Questionnaire-Trait-reduced scores as a function of NF effect from inclusion to 3 months after the end of intervention.
Food Cravings Questionnaire (FCQ), which consists of a trait (FCQ-T; 39 items) and state (FCQ-S; 15 items) version. FCQ-T-r is a self-administrated questionnaire consisted of 15-items scored using a Likert-type scale (1 = never, 2 = rarely, 3 = sometimes, 4 = usually, 6 = always), for possible total scores ranging from 15 to 90.
Difference in Food frequency questionnaire scores between groups 3 months after NF training
Variation in Food Frequency questionnaire scores as a function of NF effect from inclusion to end of intervention.
Food frequency questionnaire (FFQ) is a dietary assessment tool delivered as a questionnaire to estimate frequency and, in some cases, portion size information about food and beverage consumption over a specified period of time
Difference in Three Factor Eating Questionnaire-R18 scores between groups 3 months after NF training
Variation in Three Factor Eating Questionnaire-R18 questionnaire scores as a function of NF effect from inclusion to 3months after the end of intervention.
The Three Factor Eating Questionnaire-R18 (TFEQ-R18) consists of 18 items on a 4-point response scale (definitely true/mostly true/mostly false/definitely false). Responses to each of the 18 items are given a score between 1 and 4 and item scores are summated into scale scores for cognitive restraint, uncontrolled eating, and emotional eating. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.
Difference in Three Factor Eating Questionnaire-R18 scores between groups after NF training
Variation in Three Factor Eating Questionnaire-R18 questionnaire scores as a function of NF effect from inclusion to the end of intervention.
The Three Factor Eating Questionnaire-R18 (TFEQ-R18) consists of 18 items on a 4-point response scale (definitely true/mostly true/mostly false/definitely false). Responses to each of the 18 items are given a score between 1 and 4 and item scores are summated into scale scores for cognitive restraint, uncontrolled eating, and emotional eating. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.
Full Information
NCT ID
NCT05277714
First Posted
March 2, 2022
Last Updated
August 2, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05277714
Brief Title
Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.
Acronym
CaDOb
Official Title
Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
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
The hypothesis is that the increase in dlPFC brain activity via near-infrared spectroscopy-based Neurofeedback (fNIRS-based NF) training based on near-infrared spectroscopy would allow an improvement of the eating behavior, thus promoting a long-term weight loss in obese subjects.
Patients will be trained during a month with 8 NF sessions and results based on clinical data and different questionnaires results will be compared between inclusion and 3 months later
Detailed Description
Obesity is a disease of increasing prevalence due in part to the greater availability of fatty, sugary and/or salty foods which, when consumed chronically and in excess, can lead to food addiction.
According to the neurocognitive model of addiction, the development and maintenance of addiction is associated with deficits in cognitive control, as well as a decrease prefrontal cortex (dlPFC). Self-control in food choice situations also depends on prefrontal network with the dlPFC as a hub, strongly connected with striatal and cingulate structures.
Neurofeedback (NF) is a technique that relies on the patient's positive or negative self-regulation of brain activity. It has been shown to be effective in several pathologies, in particular attention deficit/hyperactivity disorder in young people and more recently in depression and emotion regulation.
In this study, NF will be based on near-infrared spectroscopy (fNIRS), because its use is easy mobile and inexpensive. The hypothesis is that the increase in dlPFC brain activity via fNIR-based NF training based on fNIRS would allow an improvement of the eating behavior, thus promoting a long-term weight loss in obese subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Craving
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Masking Description
sham procedure
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NF
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
The sham protocol will last 15 minutes per session, and during each session, the participants will receive the same instruction but will be shown a random signal, the goal being that the control strategy that the participant tries to implement is not correlated with the visual feedback provided by the gauge.
Intervention Type
Other
Intervention Name(s)
NF
Intervention 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 patient will have to increase the brain activity of her dlPFC using a visual gauge representing the "activity level" of 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".
Primary Outcome Measure Information:
Title
Number of patients who have a difference in resting state IRM after NF session
Description
Difference in resting state IRM at inclusion and at 1 month after the 8th NF session between sham and experimental.
Resting state IRM will allow to determine the correlation coefficient of the IRM BOLD signal fluctuations between the dlPFC and the striatum. The evolution of cognitive control by NeuroFeedback (NF) will thus be determined by a variation of this correlation coefficient and thus of the cortico-striatal connectivity at inclusion and after the 8th NF session.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of patients who have a difference in resting state IRM after NF training in the cognitive food anticipation task condition
Description
Variation in hemodynamic BOLD response in the cognitive food anticipation task condition between V1 and V8 between groups (NF vs sham).
Difference in resting state IRM at inclusion and at 1 month after the 8th NF session between sham and experimental.
Resting state IRM will allow to determine the correlation coefficient of the IRM BOLD signal fluctuations between the dlPFC and the striatum. The evolution of cognitive control by NeuroFeedback (NF) will thus be determined by a variation of this correlation coefficient and thus of the cortico-striatal connectivity at inclusion and after the 8th NF session.
Time Frame
1 month
Title
Difference in blood pressure status 3 months after NF training
Description
Evolution of health status using blood pressure (mmHg) between groups (NF vs sham) before and after participation (between V0 and V9).
Time Frame
4 months
Title
Difference in blood pressure status 3 months after NF training
Description
Evolution of health status using clinical exam criteria between groups (NF vs sham) before and after participation (between V0 and V9).
Time Frame
4 months
Title
Difference in biological check up 3 months after NF training
Description
Evolution of health status using biological check up between groups (NF vs sham) before and after participation (between V0 and V9).
Time Frame
4 months
Title
Change of degree of correlation between EGG results and resting state IRM after NF training
Description
Variation in the degree of correlation between electrogastrogramm plots and resting state MRI between V1 and V8 and between groups (NF vs sham).
Time Frame
1 month
Title
Difference in mental Heath status after NF training between groups
Description
Difference in anxiety and depression questionnaire (Hospital Anxiety and Depression Scale, questionnaire with 2 subscores, one for anxiety and one for depression. 0 = no anxiety/depression, 11 and more : anxiety/depression) after NF training between groups
Time Frame
1 month
Title
Difference in mental Heath status training between groups after 3 months
Description
Difference in anxiety and depression questionnaire (Hospital Anxiety and Depression Scale, questionnaire with 2 subscores, one for anxiety and one for depression. 0 = no anxiety/depression, 11 and more : anxiety/depression) 3 months after NF training between groups
Time Frame
4 months
Title
Difference in Food frequency questionnaire scores between groups after NF training
Description
Variation in FF questionnaire scores as a function of NF effect from inclusion to end of intervention.
Food frequency questionnaire (FFQ) is a dietary assessment tool delivered as a questionnaire to estimate frequency and, in some cases, portion size information about food and beverage consumption over a specified period of time
Time Frame
1 month
Title
Difference in Food Cravings Questionnaire-Trait-reduced scores between groups after NF training
Description
Variation in Food Cravings Questionnaire-Trait-reduced scores as a function of NF effect from inclusion to end of intervention.
Food Cravings Questionnaire (FCQ), which consists of a trait (FCQ-T; 39 items) and state (FCQ-S; 15 items) version. FCQ-T-r is a self-administrated questionnaire consisted of 15-items scored using a Likert-type scale (1 = never, 2 = rarely, 3 = sometimes, 4 = usually, 6 = always), for possible total scores ranging from 15 to 90.
Time Frame
1 month
Title
Difference in Food Cravings Questionnaire-Trait-reduced scores between groups 3 months after NF training
Description
Variation in Food Cravings Questionnaire-Trait-reduced scores as a function of NF effect from inclusion to 3 months after the end of intervention.
Food Cravings Questionnaire (FCQ), which consists of a trait (FCQ-T; 39 items) and state (FCQ-S; 15 items) version. FCQ-T-r is a self-administrated questionnaire consisted of 15-items scored using a Likert-type scale (1 = never, 2 = rarely, 3 = sometimes, 4 = usually, 6 = always), for possible total scores ranging from 15 to 90.
Time Frame
4 months
Title
Difference in Food frequency questionnaire scores between groups 3 months after NF training
Description
Variation in Food Frequency questionnaire scores as a function of NF effect from inclusion to end of intervention.
Food frequency questionnaire (FFQ) is a dietary assessment tool delivered as a questionnaire to estimate frequency and, in some cases, portion size information about food and beverage consumption over a specified period of time
Time Frame
4 months
Title
Difference in Three Factor Eating Questionnaire-R18 scores between groups 3 months after NF training
Description
Variation in Three Factor Eating Questionnaire-R18 questionnaire scores as a function of NF effect from inclusion to 3months after the end of intervention.
The Three Factor Eating Questionnaire-R18 (TFEQ-R18) consists of 18 items on a 4-point response scale (definitely true/mostly true/mostly false/definitely false). Responses to each of the 18 items are given a score between 1 and 4 and item scores are summated into scale scores for cognitive restraint, uncontrolled eating, and emotional eating. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.
Time Frame
4 months
Title
Difference in Three Factor Eating Questionnaire-R18 scores between groups after NF training
Description
Variation in Three Factor Eating Questionnaire-R18 questionnaire scores as a function of NF effect from inclusion to the end of intervention.
The Three Factor Eating Questionnaire-R18 (TFEQ-R18) consists of 18 items on a 4-point response scale (definitely true/mostly true/mostly false/definitely false). Responses to each of the 18 items are given a score between 1 and 4 and item scores are summated into scale scores for cognitive restraint, uncontrolled eating, and emotional eating. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible for obesity surgery according to the 2009 French High Authority on Health (HAS) criteria (BMI ≥40 or BMI ≥35 with comorbidities)
Right-handed
Presenting a food addiction determined by the YFAS 2.0 questionnaire ;
Affiliated to a social security system;
Having given free and informed consent in writing.
Exclusion Criteria:
Psychotic psychiatric disorders (schizophrenic disorders and bipolar disorders);
Psychotropic drugs, except antidepressants stabilized for at least 3 weeks and benzodiazepines
Addiction to alcohol or other psychoactive substances (except tobacco);
History of bariatric surgery;
Current treatment in the nutrition unit;
Insufficient command of French;
Pregnant or breast-feeding woman;
Persons of legal age under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
Contraindications to fMRI
Inability to perform the fNIRS procedure due to blockage or attenuation of the light at the capillary level
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Laure GERVAIS
Phone
0618454735
Email
marie-laure.gervais@chu-rennes.fr
Facility Information:
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHU Rennes
Phone
0299282591
First Name & Middle Initial & Last Name & Degree
Ronan Thibault, Pr
12. IPD Sharing Statement
Learn more about this trial
Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.
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