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Compulsive Eating and Brain's Reward System in Different Pathologies (BI-POTATOS)

2026年11月2日 更新者:University Hospital, Clermont-Ferrand

Bipolar Disorders, Parkinson's Disease, ObesiTy and Compulsive eAting: TransnosOlogical Assessement of the Brain's Reward System

Compulsive eating behaviors represent a significant issue across various disorders such as Parkinson's disease, bipolar disorders, and obesity.

Despite their apparent differences, these conditions share common underlying disturbances involving the brain's reward system, particularly within dopaminergic networks.6,7 Previous neuroimaging studies have consistently reported reward system connectivity impairment associated with compulsive eating, in each of these disorders. However, few studies have simultaneously explored the neurobiological similarities and specificities of this common symptom, eating behavior, when occurring in different populations and disorders.

The Bi-POTATOS project proposes an original and innovative approach by adopting a transdiagnostic perspective, employing brain imaging and comprehensive psycho-behavioral assessments to investigate common behavioral characteristics and neural circuit alterations associated with compulsive eating across these three conditions. For the first time, this study will allow a direct comparison of the cerebral signatures linked to compulsive eating behavior, clearly distinguishing between transdiagnostic vulnerabilities and features unique to each clinical condition.

The central hypothesis is that similar dysfunctions in brain regions involved in motivation and impulsive decision-making underpin compulsive eating behaviors, irrespective of the initial diagnosis. However, the underlying pathology may modulate these mechanisms, introducing certain specificities.

By clarifying these common mechanisms, the Bi-POTATOS project will not only enhance our understanding of the neurobiological etiology of these disorders but also pave the way for innovative, targeted therapeutic interventions. This project will precisely identify whether specific neural alterations constitute a universally relevant therapeutic target, or conversely, determine which alterations necessitate tailored therapeutic strategies based on the underlying pathology.

研究概览

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 1-Common Criteria (Parkinson disease, Obesity, Bipolar patients)

  • Men or women, right-handed, 18 to 80 years old

  • With or without compulsive eating according to the QEWP-R

  • No changes to long-term treatments in the previous month

  • Cooperation and understanding to strictly comply with the conditions set out in the protocol

  • Acceptance of the protocol and signing of a written informed consent

  • Affiliation to the social security system

    2-Specific criteria Parkinsonian patients (n=25 with CE, n=25 without CE)

  • Diagnosis of Parkinson's disease according to the Movement Disorders Society criteria

  • BMI<30

Obese patients (n=25 with CE, n=25 without CE)

  • Obese patients according to HAS 2022 classification
  • BMI≥30

Bipolar patients (n=25 with CE, n=25 without CE)

  • Diagnosis of bipolar disorder according to DSM 5 criteria
  • BMI<30

Exclusion Criteria:

  • 1-Common Criteria

  • Dementia (MoCA <22)

  • Severe depression (Beck Depression Inventory>30)

  • Contraindications to MRI (implanted stimulator, insulin pump, intraocular metallic foreign bodies or close to the nervous and vascular systems, claustrophobia, non-removable dental appliance, tattoo on the face or neck, …)

  • Refusal to be informed in case of incidental finding on MRI

  • History of stroke or brain trauma that may impact MRI findings

  • Patients under guardianship, deprived of freedoms or protection of justice.

  • Pregnant women, breastfeeding women

    2- Specific criteria

Parkinsonian patients:

  • People suffering from neurological pathologies other than PD
  • Patient suffering from psychiatric disorder
  • Treated with deep brain stimulation
  • Patients with severe tremor (> 3 for a tremor sub-item of the MDS-UPDRS III) or excessively severe dyskinesia contraindicating MRI

Obese patients:

  • Suffering from progressive neurological pathology and psychiatric disorder
  • Weight >220kg contraindicating MRI
  • Body (Shoulder) diameter > 220 cm contraindicating MRI
  • History of bariatric surgery
  • GLP1 treatment

Bipolar patients:

  • Suffering from neurological pathology and psychiatric disorder other than bipolar disorder
  • Current acute depressive or hypomanic episode according to DSM 5
  • Treated with deep brain stimulation or vagus nerve stimulation
  • Electroconvulsivotherapy < 6 months

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Study Group

Visit 1 : selection visit

  • Inform consent and participation agreement
  • Assessment of the disease and eating behavior disorder severity, medication taken, as well as a standard medical examination (measurement of weight, height and blood pressure) Cognitive function, impulsive trait of personality, depression, anxiety, restless legs syndrome, REM sleep behavior disorder and pain will be assessed.

Visit 2 : investigational visit

  • MRI scan
  • neuropsychological assessments

Neuropsychological assessment : motor impulsivity, motor inhibition, cognitive impulsivity (Stroop); decision making in an ambiguous context (Iowa Gambling Task), time perception (delay discounting reward task) and risk taking (Balloon analog Risk task).

MRI : The subjects will be scanned using a 3-Tesla MAGNETOM Vida scanner (Siemens, Erlangen, Germany) with a 64 channel head coil Dietician : 3 days food record

其他名称:
  • 神经心理学评估
  • 营养师

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Assessment of resting state seed-based functional connectivity from the limbic striatum (seed: ventral striatum) by MRI.
大体时间:At visit 2, between 1 and 12 weeks after patient enrollment

MRI is a 3-Tesla MAGNETOM Vida scanner (Siemens, Erlangen, Germany) with a 64 channel head coil.

The subjects were asked to hold still, with their eyes open and not to think of anything particular. Foam padding was employed to reduce head movement and earplugs were used to reduce scanner noise.

The high resolution anatomical images were obtained through a T1-weighted magnetization-prepared rapid gradient echo (MPRAGE) sequence with the following parameters: repetition time (TR): 2300 ms, echo time (TE): 3.08 ms, inversion time (IT): 900 ms, flip angle (FA): 9°, matrix: 288 x 288, 176 slices, slice thickness: 1mm.

Resting-state functional MRI images were obtained using an EPI sequence with the following parameters: TR: 3000ms, TE: 30ms, FA: 81°, field of view (FOV): 192 mm, 55 slices, slice thickness: 3.3 mm, gap between slices: 3.3 mm, pixel bandwidth: 2441 Hz/Pixel, number of time points: 180, acquisition duration: 9 minutes).

At visit 2, between 1 and 12 weeks after patient enrollment

次要结果测量

结果测量
措施说明
大体时间
Demographical data
大体时间:at visit 1, selection visit - Day 0

sex

at visit 1, selection visit - Day 0
Demographical data
大体时间:at visit 1, selection visit - Day 0

Age (year)

at visit 1, selection visit - Day 0
Demographical data
大体时间:at visit 1, selection visit - Day 0

weight (kg)

at visit 1, selection visit - Day 0
Demographical data
大体时间:at visit 1, selection visit - Day 0

size (m)

at visit 1, selection visit - Day 0
Parkinson Disease severity
大体时间:at visit 1, selection visit - Day 0

Assessment of parkinson desease with the MDS-UPDRS (Movement Disorders Society - Unified Parkinson's Disease Rating Scale ) scale, completed by the investigator.

at visit 1, selection visit - Day 0
Bipolar Disease severity
大体时间:at visit 1, selection visit - Day 0

Assessment of bipolar desease with MADRS (Montgomery-Asberg Depression Rating Scale) and YMRS (Young Mania Rating Scale) scale, completed by the investigator.

at visit 1, selection visit - Day 0
Obesity disease severity
大体时间:at visit 1, selection visit - Day 0

Obesity classification according to Health French Agency (Haute Autorité de Santé) 2022, completed by the investigator.

at visit 1, selection visit - Day 0
Impulsive trait of Personality according the Barratt impulsiveness scale (BIS-11)
大体时间:at visit 1, selection visit - Day 0

This self questionnaire is completed by the patient during the selection visit

at visit 1, selection visit - Day 0
Eating behavior disorder severity
大体时间:at visit 1, selection visit - Day 0

Self reported eating behavior disorder using 3 questionnaires (QEWP5 (Questionnaire on Eating and Weight Patterns5), DEBQ (Dutch Eating Behaviour Questionnaire) and food craving questionnaire))

at visit 1, selection visit - Day 0
Presence of Anxiety and/or depression according the Beck depression and anxiety scale
大体时间:at visit 1, selection visit - Day 0

These self questionnaires is completed by the patient during the selection visit

at visit 1, selection visit - Day 0
Presence of restless legs syndrome according the International Restless Legs Syndrome (Rating Scale)
大体时间:at visit 1, selection visit - Day 0

This questionnaire is completed by the investigator during the selection visit

at visit 1, selection visit - Day 0
Intensity and Pain caracteristics
大体时间:at visit 1, selection visit - Day 0

Patients will evaluate their pain using 2 self questionnaires (3-PDQ, BPI (Brief Pain Inventory))

at visit 1, selection visit - Day 0
Impulsive compulsive behaviors rating scale for PD (QUIP-RS)
大体时间:at visit 2, between 1 and 12 weeks after selection visit

The QUIP-RS is a brief 28-item patient-reported or clinician-rated scale developped for measure of severity of ICDs. Each item is rated on a 5-point Likert scale assessing frequency of symptoms with a range of scores from 0 (never) to 4 (very often).

at visit 2, between 1 and 12 weeks after selection visit
Spontaneous food intake
大体时间:at visit 2, between 1 and 12 weeks after selection visit

Patients will report thier spontaneous food intake for 3 days using a dietary data collected. Patient nutritional intakes will be analysed using Nutrilog software

at visit 2, between 1 and 12 weeks after selection visit
Motor impulsivity (Go/No Go task)
大体时间:at visit 2, between 1 and 12 weeks after selection visit

Motor impulsivity will be assessed with the Go/No-go task. It is a simple experimental paradigm that requires participants to respond as quickly as possible (Go) to a particular class of stimuli, for example by pressing a key on a keyboard, and not to respond to other classes of stimuli (No Go). The key behaviour measured with this experiment is the participants' ability to withhold a response on No-go trials.

at visit 2, between 1 and 12 weeks after selection visit
Motor inhibition (Stop Signal Task (SST))
大体时间:at visit 2, between 1 and 12 weeks after selection visit

The Stop Signal Task (SST) is a test that measures motor inhibition. The participant must respond quickly to Go stimuli but interrupt their response when a stop signal appears. The key index, the Stop Signal Reaction Time (SSRT), reflects the time required to stop an ongoing action. This test will be performed by neuropsychologist.

at visit 2, between 1 and 12 weeks after selection visit
Iowa Gambling Task (IGT)
大体时间:at visit 2, between 1 and 12 weeks after selection visit.

IGT assesses risk-based learning by relying on a system of rewards and punishments within a simulated context of uncertainty, representing a real-life decision-making situation.

Participants choose cards from four decks, each associated with varying amounts of monetary gains and losses. Over time, advantageous decks yield higher net rewards, while disadvantageous decks lead to net losses.

Performance on the task reflects an individual's capacity to balance immediate rewards against long-term outcomes, thereby providing insight into adaptive decision-making and risk evaluation processes.

This test will be performed by neuropsychologist.

at visit 2, between 1 and 12 weeks after selection visit.
Cognitive impulsivity (Stroop)
大体时间:at visit 2, between 1 and 12 weeks after selection visit

The Stroop Test is a cognitive task designed to evaluate attentional control and the ability to inhibit automatic responses when faced with conflicting information. Participants are asked to name the color of the ink in which words are printed, even when the word itself refers to a different color (e.g., GREEN printed in red ink). This requires suppressing the automatic tendency to read the word and instead focusing on the ink color. The difference in performance between congruent and incongruent conditions, known as the Stroop interference effect, is a key indicator of cognitive inhibition and executive control. This test will be performed by neuropsychologist.

at visit 2, between 1 and 12 weeks after selection visit
Time perception (delay discounting reward task)
大体时间:at visit 2, between 1 and 12 weeks after selection visit

Participants make choices between two alternatives: a larger reward available after a delay (across seven delay intervals) and a smaller reward available immediately. The value of the immediate reward is systematically adjusted, either increasing or decreasing, in separate blocks. The task assesses preferences for immediate versus delayed gratification using two reward types: money and food. This test will be performed by neuropsychologist.

at visit 2, between 1 and 12 weeks after selection visit
Balloon analog Risk task
大体时间:at visit 2, between 1 and 12 weeks after selection visit

Participants are given 30 balloons (by default). For each balloon, they can choose either to inflate it further or to collect their earnings. With each successful inflation, they can earn money. However, if a balloon bursts before the participant collects the potential earnings, they lose all potential gains associated with that balloon.

The average number of pumps on balloons that do not burst is the primary dependent variable in this paradigm. A higher number of pumps reflects increased risk-taking behavior. This test will be performed by neuropsychologist.

at visit 2, between 1 and 12 weeks after selection visit
Surface based (Freesurfer) and Voxel based (SPM) morphometry performed by MRI
大体时间:at visit 2, between 1 and 12 weeks after selection visit

MRI is a 3-Tesla MAGNETOM Vida scanner (Siemens, Erlangen, Germany) with a 64 channel head coil.

The subjects were asked to hold still, with their eyes open and not to think of anything particular. Foam padding was employed to reduce head movement and earplugs were used to reduce scanner noise.

The high resolution anatomical images were obtained through a T1-weighted magnetization-prepared rapid gradient echo (MPRAGE) sequence with the following parameters: repetition time (TR): 2300 ms, echo time (TE): 3.08 ms, inversion time (IT): 900 ms, flip angle (FA): 9°, matrix: 288 x 288, 176 slices, slice thickness: 1mm.

Resting-state functional MRI images were obtained using an EPI sequence with the following parameters: TR: 3000ms, TE: 30ms, FA: 81°, field of view (FOV): 192 mm, 55 slices, slice thickness: 3.3 mm, gap between slices: 3.3 mm, pixel bandwidth: 2441 Hz/Pixel, number of time points: 180, acquisition duration: 9 minutes).

at visit 2, between 1 and 12 weeks after selection visit
Structural connectivity (MRtrix and TRACTseg) performed by MRI
大体时间:at visit 2, between 1 and 12 weeks after selection visit

MRI is a 3-Tesla MAGNETOM Vida scanner (Siemens, Erlangen, Germany) with a 64 channel head coil.

The subjects were asked to hold still, with their eyes open and not to think of anything particular. Foam padding was employed to reduce head movement and earplugs were used to reduce scanner noise.

The high resolution anatomical images were obtained through a T1-weighted magnetization-prepared rapid gradient echo (MPRAGE) sequence with the following parameters: repetition time (TR): 2300 ms, echo time (TE): 3.08 ms, inversion time (IT): 900 ms, flip angle (FA): 9°, matrix: 288 x 288, 176 slices, slice thickness: 1mm.

Resting-state functional MRI images were obtained using an EPI sequence with the following parameters: TR: 3000ms, TE: 30ms, FA: 81°, field of view (FOV): 192 mm, 55 slices, slice thickness: 3.3 mm, gap between slices: 3.3 mm, pixel bandwidth: 2441 Hz/Pixel, number of time points: 180, acquisition duration: 9 minutes).

at visit 2, between 1 and 12 weeks after selection visit
Resting state seed-based functional connectivity from the limbic striatum performed by MRI
大体时间:at visit 2, between 1 and 12 weeks after selection visit

MRI is a 3-Tesla MAGNETOM Vida scanner (Siemens, Erlangen, Germany) with a 64 channel head coil.

The subjects were asked to hold still, with their eyes open and not to think of anything particular. Foam padding was employed to reduce head movement and earplugs were used to reduce scanner noise.

The high resolution anatomical images were obtained through a T1-weighted magnetization-prepared rapid gradient echo (MPRAGE) sequence with the following parameters: repetition time (TR): 2300 ms, echo time (TE): 3.08 ms, inversion time (IT): 900 ms, flip angle (FA): 9°, matrix: 288 x 288, 176 slices, slice thickness: 1mm.

Resting-state functional MRI images were obtained using an EPI sequence with the following parameters: TR: 3000ms, TE: 30ms, FA: 81°, field of view (FOV): 192 mm, 55 slices, slice thickness: 3.3 mm, gap between slices: 3.3 mm, pixel bandwidth: 2441 Hz/Pixel, number of time points: 180, acquisition duration: 9 minutes).

at visit 2, between 1 and 12 weeks after selection visit

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2029年7月1日

研究完成 (估计的)

2029年10月1日

研究注册日期

首次提交

2026年7月27日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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