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PARKINSON DISEASE (Disorder)BI-POTATOSNCT07923513

Compulsive Eating and Brain's Reward System in Different Pathologies

A study testing MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) in people with PARKINSON DISEASE (Disorder) and Bipolar 1 Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteFrance
Study dates
Dec 2026to Oct 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site
  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

    Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr

Other trials in France

About this study

Official title: 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.

Read more

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.

Being tested
MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
Keywords
reward system, compulsive eating, brain functional signatures
Medical subject headings
Parkinson Disease, Obesity, Food Addiction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)Other

    Also called Neuropsychological assessments, Dietitian

    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

Study groups in NCT07923513
Study groupRoleWhat they receive
Study GroupExperimentalVisit 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
Receives: Other: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of resting state seed-based functional connectivity from the limbic striatum (seed: ventral striatum) by MRI.

    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).

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

Secondary outcomes (23)
  1. Demographical data

    sex

    Measured: at visit 1, selection visit - Day 0

  2. Demographical data

    Age (year)

    Measured: at visit 1, selection visit - Day 0

  3. Demographical data

    weight (kg)

    Measured: at visit 1, selection visit - Day 0

  4. Demographical data

    size (m)

    Measured: at visit 1, selection visit - Day 0

  5. Parkinson Disease severity

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

    Measured: at visit 1, selection visit - Day 0

  6. Bipolar Disease severity

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

    Measured: at visit 1, selection visit - Day 0

  7. Obesity disease severity

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

    Measured: at visit 1, selection visit - Day 0

  8. Impulsive trait of Personality according the Barratt impulsiveness scale (BIS-11)

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

    Measured: at visit 1, selection visit - Day 0

  9. Eating behavior disorder severity

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

    Measured: at visit 1, selection visit - Day 0

  10. Presence of Anxiety and/or depression according the Beck depression and anxiety scale

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

    Measured: at visit 1, selection visit - Day 0

  11. Presence of restless legs syndrome according the International Restless Legs Syndrome (Rating Scale)

    This questionnaire is completed by the investigator during the selection visit

    Measured: at visit 1, selection visit - Day 0

  12. Intensity and Pain caracteristics

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

    Measured: at visit 1, selection visit - Day 0

  13. Impulsive compulsive behaviors rating scale for PD (QUIP-RS)

    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).

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

  14. Spontaneous food intake

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

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

  15. Motor impulsivity (Go/No Go task)

    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.

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

  16. Motor inhibition (Stop Signal Task (SST))

    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.

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

  17. Iowa Gambling Task (IGT)

    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.

    Measured: at visit 2, between 1 and 12 weeks after selection visit.

  18. Cognitive impulsivity (Stroop)

    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.

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

  19. Time perception (delay discounting reward task)

    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.

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

  20. Balloon analog Risk task

    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.

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

  21. Surface based (Freesurfer) and Voxel based (SPM) morphometry performed by MRI

    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).

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

  22. Structural connectivity (MRtrix and TRACTseg) performed by MRI

    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).

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

  23. Resting state seed-based functional connectivity from the limbic striatum performed by MRI

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07923513
Sponsor's protocol ID
AOI 2025 MARQUES
Other IDs
2026-A00850-51
Acronym
BI-POTATOS
Status last verified
Nov 2026
First submitted
27 Jul 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) in people with PARKINSON DISEASE (Disorder) and Bipolar 1 Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of resting state seed-based functional connectivity from the limbic striatum (seed: ventral striatum) by MRI. (time frame: At visit 2, between 1 and 12 weeks after patient enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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