fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating
NCT05200182, Not applicable, Recruiting, Rennes University Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating | ClinicalTrials.gov |
| NCT number | NCT05200182 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Rennes University Hospital | ClinicalTrials.gov |
| Conditions | Hyperphagia | ClinicalTrials.gov |
| Interventions | Neurofeedback with functional near infra-red spectroscopy, Sham Neurofeedback, oral microbiota collection, Questionnaires, resting-state fMRI, Electro gastrogram, Emotional Stroop task, Delay discount task | ClinicalTrials.gov |
| First posted | 2022-01-20 | ClinicalTrials.gov |
| Last updated | 2026-09-28 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in cortico-striatal connectivity | 4 weeks | 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 | ClinicalTrials.gov |
| Secondary | Validate during a pilot study in a healthy population without emotional hyperphagia a functional MRI task of reward anticipation (Monetary and Food Incentive Delay task) to characterize the effect of NeuroFeedback. | from enrollment to week 6 | healthy volunteers Statistical increase of brain responses (BOLD signal variation) in motivation and reward brain regions determined with fMRI task to reward anticipation (Monetary and Food Incentive Delay task) | ClinicalTrials.gov |
| Secondary | Validate a NeuroFeedback. approach targeting the nucleus accumbens by fMRI during sweet taste stimulation | from enrollment to week 6 | Statistical increase of fMRI BOLD responses in nucleus accumbens to sweet taste oral stimulation | ClinicalTrials.gov |
| Secondary | Statistical decreased in the score on the Emotional Overeating Questionnaire, evaluating emotional overeating, after vs before neurofeedback | from enrollment to week 6 | healthy volunteers with emotional overeating number of "emotions" driving equal or more than 6 days of overeating in a month, from 0 to 5 | ClinicalTrials.gov |
| Secondary | Evaluate by brain imaging (Monetary and Food Incentive Delay task in fMRI and basal cerebral perfusion) and behavioral questionnaires the effect of neurofeedback | from enrollment to week 10 | healthy volunteers with emotional overeating Neurofeedback will statistically decrease brain response (BOLD signal variation) in motivation and reward brain regions determined with fMRI task of reward anticipation for food (Monetary and Food Incentive Delay task) Neurofeedback will increase basal cerebral perfusion in prefrontal brain regions. Neurofeedback can modify statistically the outcome of behavioral questionaries (increase of controlling feeling during neurofeedback, from 1 : no control feeling, to 10: high control feeling) | ClinicalTrials.gov |
| Secondary | Evaluate the variation of the indicators of viscera-brain communication | from enrollment to week 6 | healthy volunteers with emotional overeating : oral microbiota and correlation of gastric rhythm by electrogastrogram and cerebral rhythm by resting state MRI Neurofeedback will statistically increase the correlation between gastric oscillations measured with electrogastrogram and BOLD signal oscillations in brain stem regions involved in autonomic control of gastric rhythm, measured with resting state fMRI Neurofeedback will statistically modify oral microbiota composition, considered as a proxy of eating habits, and measured as the percentage of each microbiota phylum (detected with DNA sequencing) | ClinicalTrials.gov |
| Secondary | Variation in responses to an emotional Stroop task adapted to food and body image representation | from enrollment to week 6 | Variation in responses to an emotional Stroop task adapted to food and body image representation | ClinicalTrials.gov |
| Secondary | Modification of behavioral scores : Global Physical Activity Questionnaire | from enrollment to week 10 | 16 items, each of them corresponds, depending of the duration of physical activity, to a specific metabolic equivalent, with higher metabolic equivalent corresponding to higher physical activity) | ClinicalTrials.gov |
| Secondary | Modification of behavioral scores : Internet Addiction Test | from enrollment to week 10 | 20 items, scale from 0 to 5, higher value corresponds to higher internet addiction | ClinicalTrials.gov |
| Secondary | Modification of behavioral scores : Alcohol Use Disorders Identification Test | from enrollment to week 10 | 10 items, score from 0 to 4 for each, higher value corresponds to higher alcohol use disorder | ClinicalTrials.gov |
| Secondary | Modification of behavioral scores : frequency of tobacco consumption | from enrollment to week 10 | ClinicalTrials.gov | |
| Secondary | Modification of behavioral scores : Holmes and Rahe questionnaire | from enrollment to week 10 | 43 items to select or not, higher selected items number corresponds to higher life events stress value | ClinicalTrials.gov |
| Secondary | Modification of behavioral scores : Barratt scale | from enrollment to week 10 | 34 items to select or not, higher selected items number corresponds to higher impulsivity | ClinicalTrials.gov |
| Secondary | Link behavioral traits to neurofeedback success : CRAFFT (car, relax, alone, forget, friends, trouble)questionnaire | from enrollment to week 6 | 6 items, responses "yes" or "no", higher "yes" number corresponds to higher psychotropic substance consumption | ClinicalTrials.gov |
| Secondary | Link behavioral traits to neurofeedback success : Boredom Proneness Scale | from enrollment to week 6 | 28 items, "true" or "false" answers, higher score corresponds to higher boredom proneness | ClinicalTrials.gov |
| Secondary | Link behavioral traits to neurofeedback success : World Health Organization-Five Well-Being Index (WHO-5) | from enrollment to week 6 | 5 items, scores from 0 to 5, higher score corresponds to higher well-being | ClinicalTrials.gov |
| Secondary | Link behavioral traits to neurofeedback success : Sick, Control, One stone, Fat Food (SCOFF) | from enrollment to week 6 | 4 items, "yes" or "no", higher number of "yes" corresponds to higher risk for eating disorder | ClinicalTrials.gov |
| Secondary | Link behavioral traits to neurofeedback success : Three Factor Eating Questionnaire-R18 | from enrollment to week 6 | 18 items, score from 1 to 4, higher score, depending of the different questions, correspond to higher dimension of eating behavior: cognitive restriction, disinhibition or control | ClinicalTrials.gov |
| Secondary | Link behavioral traits to neurofeedback success : Delay discount task | from enrollment to week 6 | multiple choice for different reward amount, for different delay before receiving this amount, higher amount for a short time to receive it corresponds to high impulsivity toward reward | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Emotional Stroop Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)