24-Month Open-Label Study of Home-Based Peroneal Electrical Transcutaneous NeuroModulation Using URIS ITM Device for Parkinsons Disease and Essential Tremor

What this Trial Is About

Researchers are investigating the long-term safety, tolerability, and effectiveness of a home-based peroneal electrical transcutaneous neuromodulation eTNM4 treatment using the URIS I12 device in people with Parkinsons disease PD or Essential Tremor ET. Earlier, a 6-week pilot study with 24 participants showed that this home treatment was safe, well tolerated, and had high adherence, with no treatment-related side effects. Although not designed to prove effectiveness, the pilot suggested improvements in tremor symptoms that lasted for weeks after treatment ended. This extension study aims to further evaluate these outcomes over a longer period. All participants will receive the peroneal eTNM treatment using the URIS I12 neurostimulator device. This device delivers electrical stimulation directly through the skin to the peroneal nerve. The study follows the same treatment procedure as previous studies but applies it over a longer timeframe to assess ongoing effects. This is an open-label, single-site study lasting 24 months, during which participants will continue home-based therapy under the study protocol. Participants will be monitored for safety and tolerability throughout the 24-month treatment period, with particular attention to any adverse events related to the therapy. Effectiveness will be assessed using patient self-reports and clinical scales measuring tremor severity and motor function. Researchers will also track participants adherence and overall experience with the home treatment. The study aims to provide comprehensive data on the long-term impact of this non-invasive neuromodulation therapy on symptoms related to movement disorders in PD and ET.

24-months Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor