microelectrode stimulation of DBS for Parkinson's (NCT06400017)
Improve memory with brain stimulation
- Trial ID
- NCT06400017
- Official Title
- Mechanism and Application of Deep Brain Stimulation in the Treatment of Parkinson's Disease
- Goal
- Improve memory with brain stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Beijing Tiantan Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson's Disease and Parkinsonism
- Interventions
- microelectrode stimulation of DBS
Summary For Families
They want to see whether small, targeted electrical stimulation of a deep-brain area called the substantia nigra can improve memory and other thinking problems in Parkinson's, and to learn what changes in brain signals accompany any benefit. During standard deep brain stimulation surgery that treats motor symptoms by implanting electrodes in a nearby target, researchers will use tiny electrodes to stimulate the substantia nigra while people do memory tests, then repeat tests and brain recordings one month after the implanted device is turned on. The study is looking for people aged 50 to 70 with typical Parkinson's for less than 20 years who plan to have bilateral deep brain stimulation surgery, have no major brain structural problems on imaging, and do not have severe dementia or other serious medical issues. Patients keep their usual treatments; the team will only add and monitor the extra electrical testing during and after surgery.
Locations
- Beijing Tiantan Hospital, Beijing, Beijing Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying microelectrode stimulation of DBS. They want to see whether small, targeted electrical stimulation of a deep-brain area called the substantia nigra can improve memory and other thinking problems in Parkinson's, and to learn what changes in brain signals accompany any benefit. During standard deep brain stimulation surgery that treats motor symptoms by implanting electrodes in a nearby target, researchers will use tiny electrodes to stimulate the substantia nigra while people do memory tests, then repeat tests and brain recordings one month after the implanted device is turned on. The study is looking for people aged 50 to 70 with typical Parkinson's for less than 20 years who plan to have bilateral deep brain stimulation surgery, have no major brain structural problems on imaging, and do not have severe dementia or other serious medical issues. Patients keep their usual treatments; the team will only add and monitor the extra electrical testing during and after surgery.
- Who can participate?
- Participants must be between 50 Years and 70 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 1 year and 6 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- Two evaluations are done before surgery and one evaluation is done one month after surgery.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Surgical procedure (invasive); Brain surgery / implanted device (invasive); MRI scan (non-invasive); Thinking & memory tests (non-invasive); Brain wave recording (EEG) (non-invasive). Confirm the full schedule with the study coordinator.
- Is there a medication washout in this trial?
- The washout period was 1 hour.