Parkinson's DiseaseMP-TCSP-IRMfNCT02824341
Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder
A study testing fMRI in people with Parkinson's Disease and REM Sleep Behavior Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and brainstem. Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic drugs. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, REM Sleep Behavior Disorder
- What is being tested?
- fMRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parkinson's disease (UK Parkinson's Disease Society Brain Bank Criteria)
- men or women 45 to 80 years old
- diagnosis of RBD made with polysomnographic recording
Who cannot join
- Previous history of psychosis or psychiatric disease
- History of stroke or vascular lesion on MRI.
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and brainstem.
Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so-called "reward system".
Read more
A strong link was found between these two disorders and therefore the investigators believe that RBD is associated with impaired reward system.
The main objective of this study is to evaluate differences in brain activation between PD patients with and without RBD.
The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment.
Read the detailed description
Type of study: Prospective, case control study.
Number of centers: 2 (Clermont-Ferrand and Vichy)
Patients :
The study will be performed in 75 subjects (25 PD patients with RBD, 25 PD patients without RBD and 25 healthy volunteers, age-and sex-matched without any contraindications to perform an MRI)
Study Performance :
During the first visit (J0, inclusion visit, 3 hours), each subject will perform a clinical and neurological examination (MDS-Unified Parkinson Disease Rating scale (MDS-UPDRS)) and neuropsychological assessment (depression by the Beck Depression Inventory (BDI); apathy by the Lille Apathy Rating Scale (LARS), impulsivity by the Urgency, lack of Premeditation, lack of Perseverance, Sensation Seeking scale (UPPS)) Eligible patients will be welcomed in a subsequent visit at the MRI department for the functional MRI (J0+1week, 1 hour). This session will be of about 45 minutes. The reward system was explored using an experimental task during functional Magnetic Resonance Imaging (fMRI). The name of this task is the"monetary incentive delay task".
- Conditions
- Parkinson's Disease, REM Sleep Behavior Disorder
- Being tested
- fMRI
- Keywords
- Parkinson 's disease, REM sleep behavior disorder, Reward system, Functional MRI
- Medical subject headings
- Parkinson Disease, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients with RBD | Other | The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment. Receives: Device: fMRI |
| Parkinson's disease without RBD | Other | The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment. Receives: Device: fMRI |
| Healthy volunteers | Other | The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment. Receives: Device: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal variation in each region of interest
BOLD signal variation in each region of interest (ventral tegmental area, accumbens nucleus, limbic cortex, prefrontal cortex) at the time of realisation of fMRI.
Measured: at week 1
Secondary outcomes (7)
Reaction time to the task
Measured: at week 1
Performance score to the task
Measured: at week 1
Hoehn et Yahr score
Measured: at week 1
The Unified Parkinson Disease Rating scale (MDS-UPDRS) score
Measured: at week 1
The Beck Depression Inventory score
Measured: at week 1
The Lille Apathy Rating Scale score
Measured: at week 1
The impulsivity score by the Urgency
Measured: at week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Neurodis Foundation
- Responsible party
- Sponsor
- Investigators
- Franck DURIF, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824341
- Sponsor's protocol ID
- CHU-0270
- Other IDs
- 2015-A00761-48
- Acronym
- MP-TCSP-IRMf
- Status last verified
- Mar 2018
- First submitted
- 24 Jun 2016
- Last updated
- 16 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT02824341
- Acronym / sponsor ID
- MP-TCSP-IRMf / CHU-0270
- Conditions
- Parkinson's Disease, REM Sleep Behavior Disorder
- Keywords
- Parkinson 's disease, REM sleep behavior disorder, Reward system, Functional MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Neurodis Foundation
- Study start
- Oct 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and brainstem.
Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so-called "reward system".
A strong link was found between these two disorders and therefore the investigators believe that RBD is associated with impaired reward system.
The main objective of this study is to evaluate differences in brain activation between PD patients with and without RBD.
The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment.
Detailed description
Type of study: Prospective, case control study.
Number of centers: 2 (Clermont-Ferrand and Vichy)
Patients :
The study will be performed in 75 subjects (25 PD patients with RBD, 25 PD patients without RBD and 25 healthy volunteers, age-and sex-matched without any contraindications to perform an MRI)
Study Performance :
During the first visit (J0, inclusion visit, 3 hours), each subject will perform a clinical and neurological examination (MDS-Unified Parkinson Disease Rating scale (MDS-UPDRS)) and neuropsychological assessment (depression by the Beck Depression Inventory (BDI); apathy by the Lille Apathy Rating Scale (LARS), impulsivity by the Urgency, lack of Premeditation, lack of Perseverance, Sensation Seeking scale (UPPS)) Eligible patients will be welcomed in a subsequent visit at the MRI department for the functional MRI (J0+1week, 1 hour). This session will be of about 45 minutes. The reward system was explored using an experimental task during functional Magnetic Resonance Imaging (fMRI). The name of this task is the"monetary incentive delay task".
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients with RBD | Other | Device: fMRIThe investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment. |
| Parkinson's disease without RBD | Other | Device: fMRIThe investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment. |
| Healthy volunteers | Other | Device: fMRIThe investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's disease (UK Parkinson's Disease Society Brain Bank Criteria)
- men or women 45 to 80 years old
- diagnosis of RBD made with polysomnographic recording
Key exclusion criteria (3 listed)
- Previous history of psychosis or psychiatric disease
- History of stroke or vascular lesion on MRI.
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI | Device | Healthy volunteers, Parkinson's disease patients with RBD, Parkinson's disease without RBD |
Primary outcome
BOLD signal variation in each region of interest
Time frame: at week 1
BOLD signal variation in each region of interest (ventral tegmental area, accumbens nucleus, limbic cortex, prefrontal cortex) at the time of realisation of fMRI.
7 secondary outcomes
Reaction time to the task
Time frame: at week 1
Performance score to the task
Time frame: at week 1
Hoehn et Yahr score
Time frame: at week 1
The Unified Parkinson Disease Rating scale (MDS-UPDRS) score
Time frame: at week 1
The Beck Depression Inventory score
Time frame: at week 1
The Lille Apathy Rating Scale score
Time frame: at week 1
The impulsivity score by the Urgency
Time frame: at week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck DURIF principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Parkinson's Disease and REM Sleep Behavior 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 16 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD signal variation in each region of interest (time frame: at week 1). 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 16 Mar 2018.