Reduce motor and neuropsychiatric fluctuations
- Trial ID
- NCT07404241
- Official Title
- Subthalamic and Cortical Electrophysiological Correlates of Motor and Neuropsychiatric Fluctuations in Parkinson's Disease
- Goal
- Reduce motor and neuropsychiatric fluctuations
- Status
- RECRUITING
- Sponsor
- University Hospital, Geneva
- Study Type
- OBSERVATIONAL
- Enrollment
- 30 participants
- Conditions
- PARKINSON DISEASE (Disorder)
Summary For Families
The goal is to identify specific electrical brain signals in the subthalamic nucleus and cortex that line up with the motor and neuropsychiatric ups and downs people with Parkinson's often experience. To do that, researchers will record electrophysiological activity from the STN and cortical areas around the time of deep brain stimulation surgery using the implanted electrodes while participants are on dopaminergic medication, since levodopa changes brain rhythms and symptoms; STN-DBS normally treats motor fluctuations by delivering electrical pulses to the subthalamic nucleus to modulate abnormal circuits, and these recordings may show which signals drive motor or mood swings. Adults 18 to 80 with Parkinson's in the fluctuation stage who are candidates for STN-DBS or had STN-DBS implanted 4 to 8 weeks earlier, who are on dopaminergic therapy and do not have dementia, active psychosis, or other major unstable illnesses, can be enrolled.
Locations
- Geneva University Hospital, Geneva, Switzerland
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to identify specific electrical brain signals in the subthalamic nucleus and cortex that line up with the motor and neuropsychiatric ups and downs people with Parkinson's often experience. To do that, researchers will record electrophysiological activity from the STN and cortical areas around the time of deep brain stimulation surgery using the implanted electrodes while participants are on dopaminergic medication, since levodopa changes brain rhythms and symptoms; STN-DBS normally treats motor fluctuations by delivering electrical pulses to the subthalamic nucleus to modulate abnormal circuits, and these recordings may show which signals drive motor or mood swings. Adults 18 to 80 with Parkinson's in the fluctuation stage who are candidates for STN-DBS or had STN-DBS implanted 4 to 8 weeks earlier, who are on dopaminergic therapy and do not have dementia, active psychosis, or other major unstable illnesses, can be enrolled.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 7 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.