Understanding brain activity changes in Parkinson's disease fluctuations
Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease and the Temporal Dynamics of Their Dopaminergic Modulation
This study looks at how brain activity changes in people with Parkinson's disease who are already on medication and experiencing ups and downs in their symptoms, to see how the treatment affects both movement and other symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva) |
| Trial ID | NCT06301282 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between cortical activity and the motor and non-motor fluctuations experienced by patients with Parkinson's disease during the transition from dopaminergic withdrawal to the effects of levodopa. By utilizing electroencephalographic (EEG) measurements, researchers will analyze the non-linear temporal dynamics of these fluctuations to gain insights into how dopaminergic therapy impacts both motor and non-motor symptoms. The study focuses on patients who are already on dopaminergic replacement therapy and are experiencing fluctuations in their symptoms. This innovative approach seeks to deepen the understanding of Parkinson's disease and its treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Parkinson's disease who are in the fluctuation stage and currently receiving dopaminergic replacement therapy.
Not a fit: Patients who are in the early stages of Parkinson's disease or those who are not experiencing motor and non-motor fluctuations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for Parkinson's disease, enhancing the quality of life for patients.
How similar studies have performed: While the specific approach of this study is innovative, similar studies have shown promise in understanding the dynamics of Parkinson's disease symptoms and treatment effects.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Geneva
- University Hospital, Geneva — Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Vanessa Fleury, MD — University Hospital, Geneva
- Study coordinator: Vanessa Fleury, MD
- Email: Vanessa.FleuryNissen@hcuge.ch
- Phone: +41223728337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.