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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06301282
Other study ID # 2021-02341
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 3, 2023
Est. completion date December 2025

Study information

Verified date March 2024
Source University Hospital, Geneva
Contact Vanessa Fleury, MD
Phone +41223728337
Email Vanessa.FleuryNissen@hcuge.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
assessment during the transition between OFF-levodopa (i.e. withdrawal of levodopa phase) and ON-levodopa (i.e. effect of Levodopa phase)states
Electroencephalographic measurements are taken during both motor and non-motor assessments while the transition between the OFF-levodopa and ON-levodopa states occurs

Locations

Country Name City State
Switzerland University Hospital, Geneva Geneva

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 90 minutes
Secondary 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) 90 minutes
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