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®)
Plain-Language Summary
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.