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24-months Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
Sponsor: Stimvia s.r.o.
Summary
This study investigates the long-term safety and tolerability of home peroneal eTNM® therapy using the URIS I™ device in subjects with Parkinson's disease (PD) or Essential Tremor (ET). Previously, a 6-week open-label pilot study with 24 PD or ET patients demonstrated that home-based peroneal eTNM® is safe, well-tolerated, and has a high adherence rate of over 90%. No treatment-related adverse events were observed. Although the pilot study was not designed to prove efficacy, it suggested positive effects on tremor, with improvements sustained for weeks after treatment. This extension study aims to further evaluate the long-term safety, tolerability, and efficacy of peroneal eTNM® in PD and ET patients.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-07-19
Completion Date
2026-12
Last Updated
2024-08-26
Healthy Volunteers
No
Conditions
Interventions
Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
This is a non-invasive intervention, which utilizes direct transcutaneous, electrical stimulation of the peroneal nerve
Locations (1)
Cerebrovaskulární poradna s.r.o.
Ostrava, Czechia