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

Study acronym: Cemov
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary and study completion dates: May 2025 to Jun 2028
    • Interventions: Electro gastrogram (Device), Emotional Stroop task (Behavioral), Neurofeedback with functional near infra-red spectroscopy (Device)… to Delay discount task (Behavioral), Electro gastrogram (Device), Emotional Stroop task (Behavioral), Neurofeedback with functional near…
    • Secondary endpoints expanded, about 233 words
    v6
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Minor Eligibility criteria revisedv4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2022 to Apr 7, 2022
    v3
  5. Minor Primary and study completion dates: Mar 2025 to May 2025
    • Start date: Jan 2022 to Mar 2022
    • Interventions: Neurofeedback with functional near infra-red spectroscopy (Device), Sham Neurofeedback (Device) to Electro gastrogram (Device), Emotional Stroop task (Behavioral), Neurofeedback with functional near infra-red spectroscopy (Device)…
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05200182
Lead Sponsor Rennes University Hospital
Collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conditions
(from sponsor)
Hyperphagia
Related terms Hyperphagia
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov