Reduce freezing episodes while walking
- Trial ID
- NCT06570421
- Official Title
- 24-months, Open-label, Single-Site Extension Study to Evaluate Safety, Tolerability and Efficacy of the Home-based Peroneal Electrical Transcutaneous NeuroModulation (Peroneal eTNM®) Treatment Via Nerve Stimulator URIS ITM in Treatment of Symptoms Related to Movement Disorders in Subjects With Parkinson's Disease (PD) and Essential Tremor (ET)
- Goal
- Reduce freezing episodes while walking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Stimvia s.r.o.
- Study Type
- INTERVENTIONAL
- Enrollment
- 20 participants
- Conditions
- Parkinson Disease, Essential Tremor
- Interventions
- Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
Summary For Families
It's testing whether regular home use of a peroneal nerve stimulator can safely reduce tremor and other movement problems like bradykinesia and rigidity in people with Parkinson's disease or essential tremor over a 24 month extension. The URIS ITM device delivers small electrical pulses through the skin to the peroneal nerve in the lower leg, with the idea that peripheral neuromodulation can alter motor circuit activity to ease tremor and slowness; because it is a non‑drug therapy it does not change levodopa’s pharmacology and participants are asked to keep chronic medication doses stable while effects and side effects are monitored. Adults 18 and older who completed the earlier TS004-PD study and have measurable tremor (grade 1 or higher), with PD participants also showing bradykinesia and rigidity in the on state, can join, while people with implanted electrical devices, seizure disorders, dementia, peripheral neuropathy, recent botulinum toxin, major depression, or pregnancy are excluded.
Locations
- Cerebrovaskulární poradna s.r.o., Ostrava, Czechia
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®). It's testing whether regular home use of a peroneal nerve stimulator can safely reduce tremor and other movement problems like bradykinesia and rigidity in people with Parkinson's disease or essential tremor over a 24 month extension. The URIS ITM device delivers small electrical pulses through the skin to the peroneal nerve in the lower leg, with the idea that peripheral neuromodulation can alter motor circuit activity to ease tremor and slowness; because it is a non‑drug therapy it does not change levodopa’s pharmacology and participants are asked to keep chronic medication doses stable while effects and side effects are monitored. Adults 18 and older who completed the earlier TS004-PD study and have measurable tremor (grade 1 or higher), with PD participants also showing bradykinesia and rigidity in the on state, can join, while people with implanted electrical devices, seizure disorders, dementia, peripheral neuropathy, recent botulinum toxin, major depression, or pregnancy are excluded.
- Who can participate?
- Participants must be at least 18 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 1 year and 11 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.