Transcranial Temporal Interference… for Parkinson's (NCT07309198)
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
- COMPLETED
- 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?
- 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 4 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 trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- You will receive 10 TIS sessions over two weeks, with movement assessments during the two-week treatment and again 2, 4, and 8 weeks afterward.