Improve walking and movement control
- Trial ID
- NCT07309198
- Official Title
- Effects and Mechanisms of Non-invasive Deep Brain Stimulation in Patients With Parkinson's Disease
- Goal
- Improve walking and movement control
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Shanghai University of Sport
- Study Type
- INTERVENTIONAL
- Enrollment
- 36 participants
- Conditions
- Parkinson's Disease
- Interventions
- Transcranial Temporal Interference Stimulation (TIS)
Summary For Families
They want to see whether noninvasive deep brain stimulation can change the deep motor circuits that drive Parkinson's movement problems and to learn how those changes happen. The method, transcranial temporal interference stimulation, sends two high-frequency electric fields that overlap to produce a low-frequency signal deep in the brain, modulating activity in targets like the basal ganglia without directly stimulating the scalp, and it is tested while participants keep their usual Parkinsons meds unchanged. Looking for people aged 50 to 80 with physician-diagnosed idiopathic Parkinsons, Hoehn and Yahr stages 1.5 to 3 who can walk unassisted, on a stable antiparkinsonian regimen for at least 4 weeks, and with MoCA of 21 or higher. People with MRI or stimulation contraindications, prior DBS, current antipsychotic or antidepressant use, major psychiatric illness, certain cardiovascular or orthopedic risks are excluded.
Locations
- Shanghai University of Sport, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Transcranial Temporal Interference Stimulation (TIS). They want to see whether noninvasive deep brain stimulation can change the deep motor circuits that drive Parkinson's movement problems and to learn how those changes happen. The method, transcranial temporal interference stimulation, sends two high-frequency electric fields that overlap to produce a low-frequency signal deep in the brain, modulating activity in targets like the basal ganglia without directly stimulating the scalp, and it is tested while participants keep their usual Parkinsons meds unchanged. Looking for people aged 50 to 80 with physician-diagnosed idiopathic Parkinsons, Hoehn and Yahr stages 1.5 to 3 who can walk unassisted, on a stable antiparkinsonian regimen for at least 4 weeks, and with MoCA of 21 or higher. People with MRI or stimulation contraindications, prior DBS, current antipsychotic or antidepressant use, major psychiatric illness, certain cardiovascular or orthopedic risks are excluded.
- Who can participate?
- Participants must be between 50 Years and 80 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 3 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.