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.
Study ID
NCT06570421
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) — DEVICE
    This is a non-invasive intervention, which utilizes direct transcutaneous, electrical stimulation of the peroneal nerve

Study Details

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.

Key Dates

First listed
Aug 26, 2024
Start date
Jul 19, 2024
Status verified
Aug 2024
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Peroneal eTNM arm
    All patients will receive treatment with peroneal eTNM

Primary Outcome Measure

Safety and Tolerability Assessed by Treatment Emergent Adverse Events [ Time Frame: Baseline to end of the treatment (24 months, based on the study protocol) ]

Central Contacts

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