Parkinson's Trial NCT07404241
Identify signals predicting mood fluctuations
- Trial ID
- NCT07404241
- Official Title
- Subthalamic and Cortical Electrophysiological Correlates of Motor and Neuropsychiatric Fluctuations in Parkinson's Disease
- Goal
- Identify signals predicting mood fluctuations
- Status
- RECRUITING
- Sponsor
- University Hospital, Geneva
- Study Type
- OBSERVATIONAL
- Enrollment
- 30 participants
- Conditions
- PARKINSON DISEASE (Disorder)
Summary For Families
The team wants to find brain-wave patterns that explain why movement problems and non-movement issues like mood swings, fatigue, and slowed thinking go up and down in Parkinson's, especially when medication changes. They will record high-density scalp electroencephalogram and electrical signals from the subthalamic nucleus using patients' implanted deep brain stimulation devices while giving 150% of the usual morning levodopa dose, comparing five combinations of on and off medication and on and off stimulation. Researchers will look for specific frequency bands in the cortex and deep brain that match motor versus non-motor fluctuations and use machine learning to see if those patterns can predict clinical states and inform future adaptive deep brain stimulation. The study will enroll 30 people aged 18 to 80 who have Parkinson's with motor or non-motor fluctuations, are on stable dopaminergic therapy and are candidates for or recently had subthalamic deep brain stimulation (about 4 to 8 weeks after implant), and who do not have dementia or active psychosis.
Locations
- Geneva University Hospital, Geneva, Switzerland
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The team wants to find brain-wave patterns that explain why movement problems and non-movement issues like mood swings, fatigue, and slowed thinking go up and down in Parkinson's, especially when medication changes. They will record high-density scalp electroencephalogram and electrical signals from the subthalamic nucleus using patients' implanted deep brain stimulation devices while giving 150% of the usual morning levodopa dose, comparing five combinations of on and off medication and on and off stimulation. Researchers will look for specific frequency bands in the cortex and deep brain that match motor versus non-motor fluctuations and use machine learning to see if those patterns can predict clinical states and inform future adaptive deep brain stimulation. The study will enroll 30 people aged 18 to 80 who have Parkinson's with motor or non-motor fluctuations, are on stable dopaminergic therapy and are candidates for or recently had subthalamic deep brain stimulation (about 4 to 8 weeks after implant), and who do not have dementia or active psychosis.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 7 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- 2 study visits are required, and the study's total duration is ~36 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Brain wave recording (EEG) (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.