Peroneal electrical transcutaneous… for Parkinson's (NCT06570421)
Sustain tremor improvement after stimulation
- 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
- Sustain tremor improvement after stimulation
- 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
The study is looking at whether people with Parkinson's disease or essential tremor can safely and comfortably use a home nerve-stimulating device long term, and whether the tremor benefits seen in a small six-week pilot continue over months to years. Participants will use the URIS I nerve stimulator to deliver peroneal electrical transcutaneous neuromodulation, a form of mild electrical stimulation to the peroneal nerve; in the pilot people self‑administered treatment at home with over 90% adherence, no treatment‑related side effects, and reported tremor improvements that lasted for weeks after treatment, measured visually, with motion sensors, and with validated movement rating scales. To join you must be an adult 18 or older who completed the earlier pilot, have stable medications, and have at least mild hand or arm tremor; people with implanted electrical devices, seizure disorders, dementia, active skin problems at the stimulation site, peripheral nerve damage in the legs, recent botulinum toxin injections, pregnancy, or certain other neurological or psychiatric conditions 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®). The study is looking at whether people with Parkinson's disease or essential tremor can safely and comfortably use a home nerve-stimulating device long term, and whether the tremor benefits seen in a small six-week pilot continue over months to years. Participants will use the URIS I nerve stimulator to deliver peroneal electrical transcutaneous neuromodulation, a form of mild electrical stimulation to the peroneal nerve; in the pilot people self‑administered treatment at home with over 90% adherence, no treatment‑related side effects, and reported tremor improvements that lasted for weeks after treatment, measured visually, with motion sensors, and with validated movement rating scales. To join you must be an adult 18 or older who completed the earlier pilot, have stable medications, and have at least mild hand or arm tremor; people with implanted electrical devices, seizure disorders, dementia, active skin problems at the stimulation site, peripheral nerve damage in the legs, recent botulinum toxin injections, pregnancy, or certain other neurological or psychiatric conditions 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?
- 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 1 year and 11 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.