Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease

NCT ID: NCT06301282

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-03
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Vanessa Fleury

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vanessa Fleury, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

University Hospital, Geneva

Geneva, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Vanessa Fleury, MD

Role: CONTACT

Vanessa.FleuryNissen@hcuge.ch

+41223728337

Facility Contacts

Vanessa Fleury, MD

Role: primary

Vanessa.FleuryNissen@hcuge.ch

+41223728337

Other Identifiers

2021-02341

Identifier Type: -

Identifier Source: org_study_id