Constant current (CC) subthalamic… for Parkinson's (NCT06742450)
Reduce programming and improve symptoms
- Trial ID
- NCT06742450
- Official Title
- Prospective Study of Constant Current Versus Constant Voltage Deep Brain Stimulation in Patients with Parkinson's Disease
- Goal
- Reduce programming and improve symptoms
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Xuanwu Hospital, Beijing
- Study Type
- INTERVENTIONAL
- Enrollment
- 180 participants
- Conditions
- Parkinson's Disease (PD)
- Interventions
- Constant current (CC) subthalamic nucleus deep brain stimulation, Constant voltage (CV) subthalamic nucleus deep brain stimulation
Summary For Families
The goal is to find out whether two different ways of running deep brain stimulation give better symptom control, require less programming, use less battery power, and leave doctors and patients more satisfied one year after surgery. The approach is to randomly assign people who have just had bilateral deep brain stimulation targeted to a deep brain area called the subthalamic nucleus to either a setting that keeps the electrical current steady or a setting that keeps the electrical voltage steady, then follow them for 12 months. Researchers will compare symptoms, how much programming is needed, power consumption, and both physician and patient satisfaction. About 180 adults aged 18 to 75 with Parkinson's disease who have had the device implanted but not yet turned on can join; people with dementia or serious medical problems, seizure disorders, badly placed electrodes, pregnancy, or who cannot consent or complete follow-up are not eligible.
Locations
- Xuanwu Hospital of Capital Medical University, Beijing, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Constant current (CC) subthalamic nucleus deep brain stimulation. The goal is to find out whether two different ways of running deep brain stimulation give better symptom control, require less programming, use less battery power, and leave doctors and patients more satisfied one year after surgery. The approach is to randomly assign people who have just had bilateral deep brain stimulation targeted to a deep brain area called the subthalamic nucleus to either a setting that keeps the electrical current steady or a setting that keeps the electrical voltage steady, then follow them for 12 months. Researchers will compare symptoms, how much programming is needed, power consumption, and both physician and patient satisfaction. About 180 adults aged 18 to 75 with Parkinson's disease who have had the device implanted but not yet turned on can join; people with dementia or serious medical problems, seizure disorders, badly placed electrodes, pregnancy, or who cannot consent or complete follow-up are not eligible.
- Who can participate?
- Participants must be between 18 Years and 75 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 2 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- Participants are assessed at baseline and follow-up and will be followed for up to 12 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive). Confirm the full schedule with the study coordinator.