Reduce tremor and improve gait
- Trial ID
- NCT07384442
- Official Title
- Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's Disease Patients
- Goal
- Reduce tremor and improve gait
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- YangPan
- Study Type
- INTERVENTIONAL
- Enrollment
- 50 participants
- Conditions
- Parkinson's Disease, Movement Disorders
- Interventions
- Sham Temporal Interference Stimulation, Real Temporal Interference Stimulation
Summary For Families
The goal is to reduce tremor and improve walking and balance by calming abnormal activity in the cerebellar nuclei that can worsen those problems in Parkinson's. The team uses targeted temporal interference stimulation, a noninvasive electrical method that sends two high-frequency currents through the skull so they interfere and create a low-frequency signal deep in the cerebellar nuclei, modulating their output to try to lessen tremor and improve gait while participants continue their usual levodopa rather than replace it. They are looking for people 50 or older with idiopathic Parkinson's for at least two years who have tremor and gait disturbance, respond to levodopa, have had stable medications for four weeks, can walk independently for five minutes, and do not have major cognitive impairment, recent neuromodulation, or metal implants like DBS or a pacemaker.
Locations
- Zhongnan hospital, Wuhan, Hubei, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Sham Temporal Interference Stimulation. The goal is to reduce tremor and improve walking and balance by calming abnormal activity in the cerebellar nuclei that can worsen those problems in Parkinson's. The team uses targeted temporal interference stimulation, a noninvasive electrical method that sends two high-frequency currents through the skull so they interfere and create a low-frequency signal deep in the cerebellar nuclei, modulating their output to try to lessen tremor and improve gait while participants continue their usual levodopa rather than replace it. They are looking for people 50 or older with idiopathic Parkinson's for at least two years who have tremor and gait disturbance, respond to levodopa, have had stable medications for four weeks, can walk independently for five minutes, and do not have major cognitive impairment, recent neuromodulation, or metal implants like DBS or a pacemaker.
- Who can participate?
- Participants must be at least 50 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 9 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.