No intervention for Parkinson's (NCT07336199)
Tailor brain stimulation for tremor
- Trial ID
- NCT07336199
- Official Title
- Pairing Subjective Patient Rating and Local Field Potentials for DBS Programming
- Goal
- Tailor brain stimulation for tremor
- Status
- RECRUITING
- Sponsor
- Ludwig-Maximilians - University of Munich
- Study Type
- OBSERVATIONAL
- Enrollment
- 25 participants
- Conditions
- Parkinson's Disease (PD)
- Interventions
- No intervention (observational study)
Summary For Families
The goal is to help tailor deep brain stimulation for people with Parkinson's by seeing whether patients' own ratings of how well stimulation works line up with objective brain signals, so clinicians can identify individualized "sweet spots" for stimulation. To do that, participants mark how effective each stimulation setting feels on a short visual scale while investigators record electrical signals from the implanted electrodes, with a focus on a brain rhythm called beta activity, and then link those recordings to structural and functional brain scans. The study is looking for adults 35 to 80 with confirmed idiopathic Parkinson's who already have bilateral deep brain stimulation of the subthalamic nucleus with an implanted pulse generator able to record signals, and who can give informed consent; people with dementia or severe medical or psychiatric conditions are excluded.
Locations
- LMU University Hospital, München, Germany
Frequently Asked Questions
- What is this trial testing?
- This trial is studying No intervention (observational study). The goal is to help tailor deep brain stimulation for people with Parkinson's by seeing whether patients' own ratings of how well stimulation works line up with objective brain signals, so clinicians can identify individualized "sweet spots" for stimulation. To do that, participants mark how effective each stimulation setting feels on a short visual scale while investigators record electrical signals from the implanted electrodes, with a focus on a brain rhythm called beta activity, and then link those recordings to structural and functional brain scans. The study is looking for adults 35 to 80 with confirmed idiopathic Parkinson's who already have bilateral deep brain stimulation of the subthalamic nucleus with an implanted pulse generator able to record signals, and who can give informed consent; people with dementia or severe medical or psychiatric conditions are excluded.
- Who can participate?
- Participants must be between 35 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 1 year 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.