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

6-weeks, Open-label, Single-Site Study to Evaluate Safety, Tolerability and Efficacy of the Home-based Peroneal Electrical Transcutaneous NeuroModulation (Peroneal eTNM®) Treatment Via Nerve Stimulator URIS ITM in Treatment of Symptoms Related to Movement Disorders in Subjects With Parkinson's Disease (PD) and Essential Tremor (ET)

NCT06036368•Stimvia s.r.o.

View on ClinicalTrials.gov

Summary

This is a 6-week exploratory clinical study, designed to test whether treatment with peroneal electrical trans-cutaneous stimulation can have a beneficial effects on symptoms associated with Parkinson's diseases and essential tremor.

Detailed Description

This is a 6-week, open-label, single site clinical study designed to test whether treatment with peroneal electrical trans-cutaneous stimulation (eTNM) can have a beneficial effects on symptoms associated with Parkinson's diseases (PD) and essential tremor (ET). Eligible patients will be treated with eTNM at home for 6 weeks. Primary endpoint in this study is tolerability and safety, secondary and exploratory endpoints are various scale designed to capture improvements in the most bothersome symptoms of PD or ET.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•18 years of age
•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 screening 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 epilepsy or other seizure disorder
•Severe degree of disability or dependence in daily activities \>grade 3 as measured by modified Rankin Scale (mRS)
•Presence of clinical signs or diagnosis of dementia
•Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
•Presence of clinical signs of peripheral neuropathy on lower limbs
•Presence of chorea and/or dyskinesia
•Clinical symptoms or diagnosis of major depressive disorder
•Presence of any other neurodegenerative disease. These may include multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
•Botulinum toxin injection within 6 months prior to study enrollment
+8 more criteria

Locations (1)

Cerebrovaskulární poradna s.r.o.

Ostrava, Czechia

Key Dates

Start Date

September 15, 2023

Primary Completion Date

March 31, 2024

Completion Date

June 30, 2024

Last Updated

August 21, 2024

Enrollment

ACTUAL participants

Conditions

Parkinson's DiseaseEssential Tremor

Interventions

Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)

DEVICE

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGNA

Deep Brain Stimulation Therapy in Movement Disorders

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Parkinson's Disease

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RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations