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.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Hoehn and Yahr stage 2.5 to 4
- Deep brain stimulation: Must already have a DBS device (deep brain stimulation)
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
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07635823. It is the one about "Increase time without involuntary movements". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: Nine in-person study visits are required. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: 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.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
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?
- 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.
- 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?
- Nine in-person study visits are required.
- 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.