Home brain stimulation improves walking
- Trial ID
- NCT07518290
- Official Title
- Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease: Protocol For a Double Blind Randomized Controlled Trial
- Goal
- Home brain stimulation improves walking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Shanghai University of Sport
- Study Type
- INTERVENTIONAL
- Enrollment
- 68 participants
- Conditions
- PARKINSON DISEASE (Disorder), Motor Symptoms
- Interventions
- Home-based Transcranial Temporal Interference Stimulation (HB-TIS)
Summary For Families
They're testing whether remotely supervised, home-based temporal interference brain stimulation can reduce motor symptoms like slowness, stiffness, and gait problems in people with mild-to-moderate Parkinson's. The treatment uses two high-frequency electrical currents applied through scalp electrodes that overlap inside the brain to produce a low-frequency stimulation that reaches deeper motor circuits without surgery, and sessions are done at home under remote supervision while participants keep their anti-parkinsonian medications stable. Enrollment is for people age 40 to 80 with Parkinson's at Hoehn and Yahr stages 1.5 to 3 who can walk unaided for at least 2 minutes, excluding those with DBS or metal implants, significant cognitive impairment (MoCA <21), other major neurological or orthopedic problems, or serious psychiatric illness.
Locations
- Shanghai University of Sport, Shanghai, Shanghai Municipality, China
- Shanghai University of Sport, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Home-based Transcranial Temporal Interference Stimulation (HB-TIS). They're testing whether remotely supervised, home-based temporal interference brain stimulation can reduce motor symptoms like slowness, stiffness, and gait problems in people with mild-to-moderate Parkinson's. The treatment uses two high-frequency electrical currents applied through scalp electrodes that overlap inside the brain to produce a low-frequency stimulation that reaches deeper motor circuits without surgery, and sessions are done at home under remote supervision while participants keep their anti-parkinsonian medications stable. Enrollment is for people age 40 to 80 with Parkinson's at Hoehn and Yahr stages 1.5 to 3 who can walk unaided for at least 2 minutes, excluding those with DBS or metal implants, significant cognitive impairment (MoCA <21), other major neurological or orthopedic problems, or serious psychiatric illness.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 1 year and 10 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.