Reduce tremor and movement stiffness
- Trial ID
- NCT07572903
- Official Title
- The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease: A Three-arm, Randomized, Double-blind, Parallel-controlled Study
- Goal
- Reduce tremor and movement stiffness
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- The First Affiliated Hospital of Anhui Medical University
- Study Type
- INTERVENTIONAL
- Enrollment
- 90 participants
- Conditions
- Parkinson s Disease
- Interventions
- Temporal Interference Stimulation
Summary For Families
The goal is to find out whether temporal interference stimulation can safely reduce Parkinson's motor symptoms like slowness, stiffness, and tremor by modulating the deep brain networks that control movement. Temporal interference is a noninvasive electrical technique that runs two slightly different high-frequency currents through the scalp so they intersect and produce a low-frequency signal deep in the brain, aiming to alter basal ganglia activity without surgery; the trial is randomized, three-arm, double-blind, and tests stimulation as an add-on while participants keep their Parkinson's medications stable. Adults aged 40 and up who meet standard Parkinson's diagnostic criteria, have measurable motor signs (MDS-UPDRS III ≥ 8) and Hoehn and Yahr stage 1,4, and who have had no medication changes for at least 4 weeks can join; people with DBS or prior cranial surgery, ferromagnetic implants, epilepsy, other major neuropsychiatric disorders, recent trial participation, or pregnancy are excluded.
Locations
- The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Temporal Interference Stimulation. The goal is to find out whether temporal interference stimulation can safely reduce Parkinson's motor symptoms like slowness, stiffness, and tremor by modulating the deep brain networks that control movement. Temporal interference is a noninvasive electrical technique that runs two slightly different high-frequency currents through the scalp so they intersect and produce a low-frequency signal deep in the brain, aiming to alter basal ganglia activity without surgery; the trial is randomized, three-arm, double-blind, and tests stimulation as an add-on while participants keep their Parkinson's medications stable. Adults aged 40 and up who meet standard Parkinson's diagnostic criteria, have measurable motor signs (MDS-UPDRS III ≥ 8) and Hoehn and Yahr stage 1,4, and who have had no medication changes for at least 4 weeks can join; people with DBS or prior cranial surgery, ferromagnetic implants, epilepsy, other major neuropsychiatric disorders, recent trial participation, or pregnancy are excluded.
- Who can participate?
- Participants must be at least 40 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 2 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.