Steadier brain pulses reduce tremor
- Trial ID
- NCT06742450
- Official Title
- Prospective Study of Constant Current Versus Constant Voltage Deep Brain Stimulation in Patients with Parkinson's Disease
- Goal
- Steadier brain pulses reduce tremor
- 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
They're testing whether delivering stimulation as constant current or constant voltage at the subthalamic nucleus gives steadier, more effective control of motor symptoms with fewer side effects. The approach uses bilateral STN-DBS with either constant current, which keeps the electrical current steady despite changes in tissue impedance, or constant voltage, which holds voltage steady so the actual current can vary; DBS sends pulses to normalize abnormal STN activity, improving tremor, stiffness, and slowness, and often lets people reduce or smooth out levodopa dosing. The trial seeks adults 18 to 75 with idiopathic Parkinson's who already have bilateral STN-DBS electrodes implanted but not yet powered on. People with dementia, major medical problems, epilepsy, pregnancy, severely misplaced electrodes, or inability to consent or follow up are excluded.
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. They're testing whether delivering stimulation as constant current or constant voltage at the subthalamic nucleus gives steadier, more effective control of motor symptoms with fewer side effects. The approach uses bilateral STN-DBS with either constant current, which keeps the electrical current steady despite changes in tissue impedance, or constant voltage, which holds voltage steady so the actual current can vary; DBS sends pulses to normalize abnormal STN activity, improving tremor, stiffness, and slowness, and often lets people reduce or smooth out levodopa dosing. The trial seeks adults 18 to 75 with idiopathic Parkinson's who already have bilateral STN-DBS electrodes implanted but not yet powered on. People with dementia, major medical problems, epilepsy, pregnancy, severely misplaced electrodes, or inability to consent or follow up are excluded.
- 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?
- 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 2 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.