directional Deep brain stimulation for Parkinson's (NCT07700862)
Steer stimulation to reduce tremor
- Trial ID
- NCT07700862
- Official Title
- Directional Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Tremor-dominant Parkinson's Disease: a Prospective, Randomized, Double-blinded, Cross-over Trial
- Goal
- Steer stimulation to reduce tremor
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Ruijin Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 32 participants
- Conditions
- Parkinsons Disease (PD)
- Interventions
- directional Deep brain stimulation
Summary For Families
The goal is to see whether steering current to the posterior subthalamic area, versus to the subthalamic nucleus, better controls tremor in people with tremor-dominant Parkinson's disease. The approach implants directional deep brain stimulation leads that can steer electrical current, then after two months doctors do blinded mapping to find safe, effective settings and remove any setting that causes immediate, unmanageable side effects; participants with tolerated settings move into a randomized, blinded two-month crossover of each target, followed by a two-month open period where both targets are stimulated together, and everyone is followed up to 12 months after surgery. The trial is looking for adults 18 to 80 with idiopathic, tremor-dominant Parkinson's when off medication, with moderate disease (stage 2 to 4 on a standard Parkinson's scale when off meds), who have been on regular Parkinson's medicines for more than six weeks and can give informed consent. People with atypical parkinsonism, prior stroke or other major brain problems, significant cognitive or psychiatric illness, anatomical abnormalities at the target, or other medical issues that raise surgical risk are excluded.
Locations
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying directional Deep brain stimulation. The goal is to see whether steering current to the posterior subthalamic area, versus to the subthalamic nucleus, better controls tremor in people with tremor-dominant Parkinson's disease. The approach implants directional deep brain stimulation leads that can steer electrical current, then after two months doctors do blinded mapping to find safe, effective settings and remove any setting that causes immediate, unmanageable side effects; participants with tolerated settings move into a randomized, blinded two-month crossover of each target, followed by a two-month open period where both targets are stimulated together, and everyone is followed up to 12 months after surgery. The trial is looking for adults 18 to 80 with idiopathic, tremor-dominant Parkinson's when off medication, with moderate disease (stage 2 to 4 on a standard Parkinson's scale when off meds), who have been on regular Parkinson's medicines for more than six weeks and can give informed consent. People with atypical parkinsonism, prior stroke or other major brain problems, significant cognitive or psychiatric illness, anatomical abnormalities at the target, or other medical issues that raise surgical risk are excluded.
- 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 5 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 a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.
- 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.