Parkinson DiseaseTransitionNCT06301282
Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease
An observational study of Parkinson Disease, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Dopaminergic replacement therapy while efficient at reducing symptoms of Parkinson's disease is however often associated with motor and non-motor fluctuations which have a severe impact on patient quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- assessment during the transition between OFF-levodopa (i.e. withdrawal of levodopa phase) and ON-levodopa (i.e. effect of Levodopa phase)states
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Mar 2023to Dec 2025
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's Disease (PD) patients will be recruited from the outpatient movement disorder clinic of the Neurology Department at the Geneva University Hospital (HUG). Patients, who participated in previous studies and who are now followed-up by private physicians, could also be contacted by trained members of the clinic/research staff to propose the study. Flyers with a brief explanation of the project could also be distributed to the physicians for inviting patients to consider participating and reach out to a staff member for further information. Healthy controls will be recruited among the spouse of patients and through advertisement placed in the HUG and the University Medical Centre.
Who may be able to join
- Diagnosis of Parkinson's disease (PD) based on United Kingdom PD Society Brain Bank Criteria
- Patients in the PD phase called "fluctuation stage". PD can be defined according to the four following disease stages: de novo stage (i.e. at the time of diagnosis, dopamine replacement therapy not yet introduced), honeymoon stage (i.e. dopamine replacement therapy compensates PD symptoms), motor and non-motor fluctuations stage (fluctuations in the clinical effect of the dopamine replacement therapy) and the decline phase (i.e. onset of cognitive impairment and falls).
- Presence of motor and non-motor fluctuations are based on:
- For motor fluctuations: a score of 1 on item 4.1 and/or 1 on item 4.3 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale IV
- For non-motor fluctuations: a score of 2 on item III of the Behavioral Assessment of PD
- To be on dopaminergic replacement therapy. The daily dose of dopaminergic replacement therapy will be converted into a common unit (levodopa equivalent daily dose) to get an idea of the dopaminergic replacement therapy dose needed per day for each patient
Show all 9Show fewer
- The course of PD, and in particular the time of each PD phase, is very variable from one patient to another. A precise duration of illness can therefore not be included in the inclusion criteria. The dose of dopaminergic replacement therapy required for each patient is also extremely variable from one patient to another and cannot be included in the inclusion criteria.
- Healthy controls will be subjects:
- Without any known central nervous system (CNS) lesion or CNS clinical signs on examination
Who cannot join
- Age greater than 80 years
- Dementia or mild cognitive impairment based on a score <24 on the MOntreal Cognitive Assessment,
- Ongoing depression with suicidal ideation,
- Any clinically meaningful non-stable renal, hepatic, cardiovascular, respiratory, cerebrovascular disease or other serious progressive physical diseases,
- Participating in a pharmacological study,
- Intolerable "OFF-levodopa" states when the effects of the PD medication wear off (e.g., severe pain, anxiety, depression at the end of the dose or in the morning upon waking),
- Inability to provide informed consent (legal guardianship),
- Inability to speak or read French.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital, Geneva
Geneva, 1204
Vanessa Fleury, MD, +41223728337, Vanessa.FleuryNissen@hcuge.ch
About this study
Official title: Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease and the Temporal Dynamics of Their Dopaminergic Modulation
Dopaminergic replacement therapy while efficient at reducing symptoms of Parkinson's disease is however often associated with motor and non-motor fluctuations which have a severe impact on patient quality of life. To date, the interplay between cortical activity linked to motor and non-motor symptoms and Parkinson's disease fluctuations linked to dopaminergic medication remain poorly understood.
The aim of the study is to characterize the cortical electroencephalographic oscillatory correlates of Parkinson's disease motor and non-motor fluctuations and the temporal dynamics of their dopaminergic modulation.
Read more
For this purpose, the investigators will apply an innovative approach using the differential non-linear temporal dynamics of motor and non-motor state during the transition from the dopaminergic withdrawal phase (i.e. OFF-levodopa state) to the dopaminergic effect phase (i.e. ON-levodopa state) following an acute levodopa administration.
This research will allow to precisely disentangle the network dynamics subtending motor and non-motor symptoms of Parkinson's disease as well as precisely identify the electroencephalographic spectral modulations explaining the neuropsychiatric effects of levodopa. The identification of such biomarkers could pave the way toward innovative therapeutic approaches such as neurofeedback and transmagnetic stimulation.
- Conditions
- Parkinson Disease
- Being tested
- assessment during the transition between OFF-levodopa (i.e. withdrawal of levodopa phase) and ON-levodopa (i.e. effect of Levodopa phase)states
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment during the transition between OFF-levodopa (i.e. withdrawal of levodopa phase) and ON-levodopa (i.e. effect of Levodopa phase)statesBehavioural
Electroencephalographic measurements are taken during both motor and non-motor assessments while the transition between the OFF-levodopa and ON-levodopa states occurs
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of electroencephalographic resting-state oscillatory activity with neuropsychiatric clinical scores during the levodopa challenge
Correlation between electroencephalographic data (frequency, time, cortical location) and neuropsychiatric scores (neuropsychiatric fluctuation score, anxiety and depression scores, apathy score, bradyphrenia score)
Measured: 90 minutes
Secondary outcomes (1)
Correlation of electroencephalographic resting-state oscillatory activity with motor scores during the levodopa challenge
Correlation of electroencephalographic resting-state oscillatory activity with motor scores (akinesia, rigidity)
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start3 Mar 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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 University Hospital, GenevaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Fleury, University Hospital, Geneva
- Investigators
- Vanessa Fleury, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301282
- Sponsor's protocol ID
- 2021-02341
- Acronym
- Transition
- Status last verified
- Mar 2024
- First submitted
- 16 Jan 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease and the Temporal Dynamics of Their Dopaminergic Modulation
- ClinicalTrials.gov ID
- NCT06301282
- Acronym / sponsor ID
- Transition / 2021-02341
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Mar 2024 (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.
Dopaminergic replacement therapy while efficient at reducing symptoms of Parkinson's disease is however often associated with motor and non-motor fluctuations which have a severe impact on patient quality of life. To date, the interplay between cortical activity linked to motor and non-motor symptoms and Parkinson's disease fluctuations linked to dopaminergic medication remain poorly understood.
The aim of the study is to characterize the cortical electroencephalographic oscillatory correlates of Parkinson's disease motor and non-motor fluctuations and the temporal dynamics of their dopaminergic modulation.
For this purpose, the investigators will apply an innovative approach using the differential non-linear temporal dynamics of motor and non-motor state during the transition from the dopaminergic withdrawal phase (i.e. OFF-levodopa state) to the dopaminergic effect phase (i.e. ON-levodopa state) following an acute levodopa administration.
This research will allow to precisely disentangle the network dynamics subtending motor and non-motor symptoms of Parkinson's disease as well as precisely identify the electroencephalographic spectral modulations explaining the neuropsychiatric effects of levodopa. The identification of such biomarkers could pave the way toward innovative therapeutic approaches such as neurofeedback and transmagnetic stimulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's Disease (PD) patients will be recruited from the outpatient movement disorder clinic of the Neurology Department at the Geneva University Hospital (HUG). Patients, who participated in previous studies and who are now followed-up by private physicians, could also be contacted by trained members of the clinic/research staff to propose the study. Flyers with a brief explanation of the project could also be distributed to the physicians for inviting patients to consider participating and reach out to a staff member for further information. Healthy controls will be recruited among the spouse of patients and through advertisement placed in the HUG and the University Medical Centre.
Key inclusion criteria (9 listed)
- Diagnosis of Parkinson's disease (PD) based on United Kingdom PD Society Brain Bank Criteria
- Patients in the PD phase called "fluctuation stage". PD can be defined according to the four following disease stages: de novo stage (i.e. at the time of diagnosis, dopamine replacement therapy not yet introduced), honeymoon stage (i.e. dopamine replacement therapy compensates PD symptoms), motor and non-motor fluctuations stage (fluctuations in the clinical effect of the dopamine replacement therapy) and the decline phase (i.e. onset of cognitive impairment and falls).
- Presence of motor and non-motor fluctuations are based on:
- To be on dopaminergic replacement therapy. The daily dose of dopaminergic replacement therapy will be converted into a common unit (levodopa equivalent daily dose) to get an idea of the dopaminergic replacement therapy dose needed per day for each patient
- The course of PD, and in particular the time of each PD phase, is very variable from one patient to another. A precise duration of illness can therefore not be included in the inclusion criteria. The dose of dopaminergic replacement therapy required for each patient is also extremely variable from one patient to another and cannot be included in the inclusion criteria.
Key exclusion criteria (8 listed)
- Age greater than 80 years
- Dementia or mild cognitive impairment based on a score <24 on the MOntreal Cognitive Assessment,
- Ongoing depression with suicidal ideation,
- Any clinically meaningful non-stable renal, hepatic, cardiovascular, respiratory, cerebrovascular disease or other serious progressive physical diseases,
- Participating in a pharmacological study,
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 |
|---|---|---|
| assessment during the transition between OFF-levodopa (i.e. withdrawal of levodopa phase) and ON-levodopa (i.e. effect of Levodopa phase)statesElectroencephalographic measurements are taken during both motor and non-motor assessments while the transition between the OFF-levodopa and ON-levodopa states occurs | Behavioural | – |
Primary outcome
Correlation of electroencephalographic resting-state oscillatory activity with neuropsychiatric clinical scores during the levodopa challenge
Time frame: 90 minutes
Correlation between electroencephalographic data (frequency, time, cortical location) and neuropsychiatric scores (neuropsychiatric fluctuation score, anxiety and depression scores, apathy score, bradyphrenia score)
1 secondary outcome
Correlation of electroencephalographic resting-state oscillatory activity with motor scores during the levodopa challenge
Time frame: 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Vanessa Fleury, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University Hospital, Geneva at 1 site in Switzerland.
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 9 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 8 Mar 2024. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Fleury, MD (+41223728337, Vanessa.FleuryNissen@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of electroencephalographic resting-state oscillatory activity with neuropsychiatric clinical scores during the levodopa challenge (time frame: 90 minutes). 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 8 Mar 2024.