NCT07404241 Neural Correlates of Motor and Psychiatric Fluctuations in Parkinson's Disease
| NCT ID | NCT07404241 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Geneva |
| Condition | PARKINSON DISEASE (Disorder) |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-06-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study explores the electrophysiological mechanisms underlying motor and non-motor fluctuations (NMF) in Parkinson's disease (PD), focusing on cortical and subthalamic dynamics during acute dopaminergic stimulation. PD is characterized by both motor symptoms and disabling non-motor symptoms-including neuropsychiatric fluctuations that remain poorly understood. While local field potentials (LFP) recorded from the subthalamic nucleus (STN) via deep brain stimulation (DBS) have revealed beta-band abnormalities linked to motor dysfunction, little is known about the oscillatory signatures of NMF. Preliminary data from our group suggested that gamma-band EEG activity in frontotemporal regions may correlate with neuropsychiatric fluctuations. This Swiss, two-center, prospective observational study aims to investigate resting-state electroencephalogram (EEG) and STN-LFP correlates of motor and non-motor symptoms during a modified levodopa challenge in 30 PD patients with STN-DBS. Using high-density EEG and chronically implanted Medtronic Percept™ DBS devices, electrophysiological data will be collected across five clinical states (combinations of ON/OFF levodopa and DBS). Clinical symptoms will be assessed alongside electrophysiological activity to identify frequency-specific cortical-STN biomarkers. Machine learning models (e.g., LASSO regression) will be used to predict motor and non-motor states from EEG and LFP data, enabling the identification of dynamic oscillatory markers. This could inform future adaptive DBS strategies. The study leverages advanced methods in neurophysiology, imaging, and machine learning to deepen our understanding of PD fluctuations. It also proposes the first detailed electrophysiological mapping of NMF, which could improve patient stratification and neuromodulation therapies. Anatomical validation of DBS lead placement will be performed using standard neuroimaging toolkits.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Parkinson's disease (PD) based on United Kingdom Parkinson's Disease Society Brain Bank Criteria. * Patients candidate for STN-DBS in the PD phase called fluctuations stage. * Presence of fluctuations (motor and/or non-motor) are based on the pre-surgical DBS assessment: * To be on dopaminergic therapy. * Patients who have undergone STN-DBS implantation within 4 to 8 weeks before electrophysiological acquisition. Exclusion Criteria: * Patients with an age greater than 80 years, * Dementia (defined by a MOCA score ≤24), * Active psychosis or depression with suicidal ideation, * Any clinically meaningful non-stable physical diseases, * Patients with OFF-drug state so severe that it prevents study tests from being carried out (e.g acute painful dystonia, intolerable non-motor symptoms such as pain, anxiety), * Participating in a pharmacological study, * Inability to provide informed consent (legal guardianship).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07404241 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying PARKINSON DISEASE (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07404241 currently recruiting?
Yes, NCT07404241 is actively recruiting participants. Contact the research team at damien.benis@hug.ch for enrollment information.
Where is the NCT07404241 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT07404241 clinical trial?
NCT07404241 is sponsored by University Hospital, Geneva. The trial plans to enroll 30 participants.
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