Parkinson DiseaseCOMPARENCT05640986
Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease
A study testing BART-EEG at V1 + V2 and BART-EEG at V1 only in people with Parkinson Disease, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The Balloon Analogue Risk Task [BART] is an experimental task modelizing risky behaviors. In Parkinson disease, the correlation between BART and modifications of cerebral activity in ventral striatum has been shown. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- BART-EEG at V1 + V2 and BART-EEG at V1 only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2023to 2 Apr 2026
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Probable Diagnosis of Parkinson's disease according to the Movement Disorder Society criteria
- Parkinson disease appeared ≤ 60 years old
- Disease evolving since ≥ 5 years
- Daily dose for du dopaminergic treatment ≥ 200mg/day DOPA equivalent
- Patients requiring in routine care the introduction or increase of dopaminergic agonists treatment because of:
- HYPOdopaminergic behavioral syndrome [TYPO] including apathy, anxiety, depression and/or
- motor syndrome insufficiently controlled by dopaminergic treatment (akinesia, rigidity, tremor)
Who cannot join
- Cognitive disorders (Montreal Cognitive Assessment [MoCA] < 25/30)
- Parkinson disease psychosis
- HYPERdopaminergic behavioral disorders [TYPER] defined by a score ≥ 2 at at least 1 item of HYPERdopaminergic behavioral spectrum of Parkinson disease
- Contraindications for dopaminergic agonists
- Patient treated with deep brain stimulation
- Serious psychiatric comorbidity (major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders [DSM] V criteria, suicidal patient, other active psychosis, etc.)
- Unstabilized psychotropic treatment
- Pregnant or breastfeeding women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease: a Pilot Study
The Balloon Analogue Risk Task [BART] is an experimental task modelizing risky behaviors. In Parkinson disease, the correlation between BART and modifications of cerebral activity in ventral striatum has been shown. BART thus seems to be particularly adapted for modelization of HYPERdopaminergic behavioral disorders [TYPER] into Parkinsonian patients. Previously, a version of the BART performed with EEG has been specifically developped by the Centre d'Investigation Clinique of Besançon University Hospital, in collaboration with the Clinical and integrative neurosciences laboratory. Preliminary data suggest that the analysis of evoked potentials including Feedback-related Negativity [FRN], P300 wave, and Reward Positivity [RewP], could help assessing the motivational and attentional attributes of decision making and the delayed treatment of any reward.
The hypothesis of the study that the EEG version of the BART could help predicting the risk to develop TYPER into Parkinsonian patients treated by dopaminergic in routine care.
- Conditions
- Parkinson Disease
- Being tested
- BART-EEG at V1 + V2, BART-EEG at V1 only
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BART-EEG at V1 + V2Behavioural
Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 + V2 for Parkinsonian patients
BART-EEG at V1 onlyBehavioural
Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 only for healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Risky behaviors assessed through BART-EEG among Parkinsonian patients newly treated with dopaminergic agonists Receives: Behavioral: BART-EEG at V1 + V2 |
| Control | Active comparator | Risky behaviors assessed through BART-EEG among healthy volunteers Receives: Behavioral: BART-EEG at V1 only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve for dopaminergic agonist treatment
Area Under the Curve / Receiver Operating Characteristic Curve [AUC-ROC] of [FRN] amplitude measured at baseline for TYPER risk 9 months after introduction or increase of dopaminergic agonist treatment
Measured: Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start2 Jan 2023 (estimated)
- Primary completion2 Apr 2026 (estimated)
- Study completion2 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu BEREAU, MD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640986
- Sponsor's protocol ID
- 2021/615
- Acronym
- COMPARE
- Status last verified
- Dec 2022
- First submitted
- 29 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT05640986
- Acronym / sponsor ID
- COMPARE / 2021/615
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 2 Jan 2023 (estimated)
- Primary completion
- 2 Apr 2026 (estimated)
- Study completion
- 2 Apr 2026 (estimated)
- First posted
- 7 Dec 2022 (actual)
- 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.
The Balloon Analogue Risk Task [BART] is an experimental task modelizing risky behaviors. In Parkinson disease, the correlation between BART and modifications of cerebral activity in ventral striatum has been shown. BART thus seems to be particularly adapted for modelization of HYPERdopaminergic behavioral disorders [TYPER] into Parkinsonian patients. Previously, a version of the BART performed with EEG has been specifically developped by the Centre d'Investigation Clinique of Besançon University Hospital, in collaboration with the Clinical and integrative neurosciences laboratory. Preliminary data suggest that the analysis of evoked potentials including Feedback-related Negativity [FRN], P300 wave, and Reward Positivity [RewP], could help assessing the motivational and attentional attributes of decision making and the delayed treatment of any reward.
The hypothesis of the study that the EEG version of the BART could help predicting the risk to develop TYPER into Parkinsonian patients treated by dopaminergic in routine care.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Behavioral: BART-EEG at V1 + V2Risky behaviors assessed through BART-EEG among Parkinsonian patients newly treated with dopaminergic agonists |
| Control | Active comparator | Behavioral: BART-EEG at V1 onlyRisky behaviors assessed through BART-EEG among healthy volunteers |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Probable Diagnosis of Parkinson's disease according to the Movement Disorder Society criteria
- Parkinson disease appeared ≤ 60 years old
- Disease evolving since ≥ 5 years
- Daily dose for du dopaminergic treatment ≥ 200mg/day DOPA equivalent
- Patients requiring in routine care the introduction or increase of dopaminergic agonists treatment because of:
Key exclusion criteria (8 listed)
- Cognitive disorders (Montreal Cognitive Assessment [MoCA] < 25/30)
- Parkinson disease psychosis
- HYPERdopaminergic behavioral disorders [TYPER] defined by a score ≥ 2 at at least 1 item of HYPERdopaminergic behavioral spectrum of Parkinson disease
- Contraindications for dopaminergic agonists
- Patient treated with deep brain stimulation
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 |
|---|---|---|
| BART-EEG at V1 + V2Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 + V2 for Parkinsonian patients | Behavioural | Patients |
| BART-EEG at V1 onlyBalloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 only for healthy volunteers | Behavioural | Control |
Primary outcome
Area under curve for dopaminergic agonist treatment
Time frame: Month 9
Area Under the Curve / Receiver Operating Characteristic Curve [AUC-ROC] of [FRN] amplitude measured at baseline for TYPER risk 9 months after introduction or increase of dopaminergic agonist treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
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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.
Matthieu BEREAU, MD principal investigator
CHU de Besançon
Questions about this trial
What is this clinical trial studying?
A study testing BART-EEG at V1 + V2 and BART-EEG at V1 only in people with Parkinson Disease, run by Centre Hospitalier Universitaire de Besancon.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu BEREAU, MD (0033381668248, mbereau@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve for dopaminergic agonist treatment (time frame: Month 9). 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 12 Dec 2022.