adaptive deep brain stimulation for Parkinson's (NCT07635823)
Increase time without involuntary movements
- Trial ID
- NCT07635823
- Official Title
- Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial
- Goal
- Increase time without involuntary movements
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Beijing Pins Medical Co., Ltd
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease(PD)
- Interventions
- adaptive deep brain stimulation, conventional deep brain stimulation
Summary For Families
The goal is to see if PINS Medical's rechargeable implanted closed-loop deep brain stimulation system (called G1010R) can increase daily time without troublesome involuntary movements, reduce periods when medication wears off, and improve movement, sleep, and overall quality of life. Participants will have the device surgically implanted and then try two ways of using it: adaptive closed-loop stimulation that automatically adjusts using real-time brain signals and sleep monitoring, and traditional continuous stimulation with fixed settings, with each person testing both options while blinded. The trial is looking for adults 18 and older with idiopathic Parkinson's whose symptoms are moderate to advanced when off medication (stage 2.5 to 4), either new candidates for bilateral stimulation surgery or existing bilateral stimulation patients with only one battery who respond to conventional therapy and agree to replace their device. Participants must be able to give written consent and complete all study visits and procedures.
Locations
- The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Hefei, Anhui, China
- Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China
- Xuanwu Hospital, Capital Medical University, Beijing, Beijing Municipality, China
- Peking Union Medical College Hospital, Beijing, Beijing Municipality, China
- First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
- Xiangya Hospital of Central South University, Changsha, Hunan, China
- Nanjing Brain Hospital, Nanjing, Jiangsu, China
- Qilu Hospital of Shandong University, Jinan, Shandong, China
- West China Hospital, Chengdu, Sichuan, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying adaptive deep brain stimulation. The goal is to see if PINS Medical's rechargeable implanted closed-loop deep brain stimulation system (called G1010R) can increase daily time without troublesome involuntary movements, reduce periods when medication wears off, and improve movement, sleep, and overall quality of life. Participants will have the device surgically implanted and then try two ways of using it: adaptive closed-loop stimulation that automatically adjusts using real-time brain signals and sleep monitoring, and traditional continuous stimulation with fixed settings, with each person testing both options while blinded. The trial is looking for adults 18 and older with idiopathic Parkinson's whose symptoms are moderate to advanced when off medication (stage 2.5 to 4), either new candidates for bilateral stimulation surgery or existing bilateral stimulation patients with only one battery who respond to conventional therapy and agree to replace their device. Participants must be able to give written consent and complete all study visits and procedures.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 9 locations.
- 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 1 year.
- 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.
- How many visits does this trial involve?
- There are nine study visits across five trial phases.
- 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.