24-months Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
Recruiting
N/A
Interventional Study
Parkinson Disease
Essential Tremor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Stimvia s.r.o. · Industry
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About This Trial
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 eve…
Trial Locations
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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 requirement…
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