NCT06570421 24-months Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
| NCT ID | NCT06570421 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stimvia s.r.o. |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2026-07 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * Has completed participation in study TS004-PD * Competent and willing to provide written, informed consent to participate in the study. * Stable dose of any chronic medications, if applicable, for 30 days prior to study entry * Willing to comply with study protocol requirements. * Subject agrees not to participate in another study from 30 days prior the baseline visit until the final study visit. * For subjects with PD: * Bradykinesia in "on" period based on clinical assessment * Rigidity in "on" period based on clinical assessment * Hand/arm exhibiting tremor (resting and/or intentional and/or postural) ≥ grade 1 as assessed by the MDS-UPDRS tremor score in "on" period * For subjects with ET: * Visible hand/arm and/or foot/leg tremor (resting and/or intentional and/or postural) ≥ grade 1 as assessed by the TETRAS Exclusion Criteria: * Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator * Suspected or diagnosed epileps
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