24-months Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
NCT Number: NCT06570421
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease|Essential Tremor
Interventions: DEVICE: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
Sponsor: Stimvia s.r.o.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-19
Completion Date: 2026-12
Locations: Cerebrovaskulární poradna s.r.o., Ostrava, 70200, Czechia

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.

Primary Outcome Measures: Safety and Tolerability Assessed by Treatment Emergent Adverse Events, Safety and tolerability based on all safety data collected in the study, including number and type of treatment emergent adverse events (TRAEs)., Baseline to end of the treatment (24 months, based on the study protocol)
Secondary Outcome Measures: Therapy Response Measured by Patient Global Impression of Improvement (PGI-I) Scale, Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better), Baseline to end of the treatment (24 months, based on the study protocol)
Other Outcome Measures: Exploratory endpoints, The Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score (both total score and subscores) (applicable only for subjects with PD)(0-260, lower score = better), Baseline to end of the treatment (24 months, based on the study protocol)|Exploratory endpoints, Essential tremor rating assessment scale (TETRAS) score (applicable only for subjects with ET, 0-64, lower scores = better)), Baseline to end of the treatment (24 months, based on the study protocol)|Exploratory endpoints, Tremor intensity measured visually (including camera recordings) in millimetres (a higher number = a more intensive tremor), Baseline to end of the treatment (24 months, based on the study protocol)|Exploratory endpoints, Quality of life measured by European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L)(0.532-1.000, higher score = better), Baseline to end of the treatment (24 months, based on the study protocol)|Exploratory endpoints, Quality of Life in Essential Tremor Questionnaire (QUEST) - applicable only for subjects with ET (0 - 100, lower score better), Baseline to end of the treatment (24 months, based on the study protocol)|Exploratory endpoints, Safety assessments:

* Adverse events (AEs)
* Treatment-emergent adverse events (TRAEs)
* Serious adverse events (SAEs)
* Serious adverse device effects (SADEs) - both anticipated SADEs (ASADEs) and unanticipated SADEs (USADEs), Baseline to end of the treatment (24 months, based on the study protocol)|Exploratory endpoints, Patient satisfaction using the Treatment Satisfaction Visual Analog scale (TS-VAS)(0-100, higher score = better), Baseline to end of the treatment (24 months, based on the study protocol)|Exploratory endpoints, Disease-specific quality of life measured by Parkinson's Disease Questionnaire (PDQ -39)(0-100, lower score = better), Baseline to end of the treatment (24 months, based on the study protocol)