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Long-term testing of nerve stimulation at home

Researchers study the safety and tolerability of a home device that stimulates a nerve through the skin in people with Parkinson’s or essential tremor.

Testing a treatment or activity · Study reference: NCT06570421

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Start (reported actual date)
2024-07-19
Main measurements finished (planned)
2026-07
Study finished (planned)
2026-12

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age 18 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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 epilepsy or other seizure disorder * 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 * Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control (these are methods with a failure quotient of \<1% year such as hormonal implants, injectable contraceptives, oral contraceptives of combination type, intra-uterine pessaries restricted to hormone contraceptive coil, sexual abstinence or vasectomy of the partner). The pregnancy test in urine at Visits 1 needs to be negative in women of childbearing potential. * Subjects unable to communicate effectively with the investigator and staff * Life expectancy less than 6 months * Subject with active malignant disease * Subject who, in the opinion of the physician, may interfere with optimal participation in the clinical trial or may pose a risk to the subject * Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol
Full study name & original research details

Official study title

24-months, Open-label, Single-Site Extension 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)

Short title used by the registry

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

Original description

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.

Further description from the registry

This is a study to investigate the long-term safety and tolerability of home peroneal eTNM® delivered by URIS I™ in subjects with PD or ET. The safety, tolerability and efficacy of the home-based peroneal eTNM® using URIS ITM neurostimulator in the treatment of symptoms related to movement disorders in subjects with PD and ET has been recently investigated in the study (NTC06036368). This 6-weeks, open-label, single-site pilot study enrolled 24 patients with either PD or ET and was completed in April 2024. This pilot study showed that home-based peroneal eTNM® was safe and well tolerated by patients. No adverse events related to treatment were observed during the study period. These data confirm the excellent safety profile of the peroneal eTNM® that has been observed in previous studies in the overactive bladder population. In addition, all patients were able to stimulate themselves at home without assistance. Adherence to the treatment was very high, reaching well over 90 %. Although this pilot study was not designed to demonstrate the efficacy of peroneal eTNM®, due to its pilot nature and the small sample size, the observed results suggest noteworthy positive effects on rest, postural and kinetic tremor as measured visually, by accelerometers and by validated MDS-UPDRS and TETRAS scales. Importantly, patients reported sustained improvement in tremor throughout the treatment and continuously for several weeks after conclusion of the 6 weeks stimulation period. Data obtained at EoS visit (6 weeks after the last stimulation) lend support for a long-lasting persistence of the effect. Based on these data, the present extension study is designed to evaluate the long-term safety, tolerability and efficacy of peroneal eTNM® in patients with PD and ET. The study will use the medical device URIS I™, which has been assessed for conformity and issued a declaration of conformity. This agent will be used for a different indication, or on a different group of patients, however, without any change in the procedure of use. The clinical trial will be conducted in accordance with clinical trial plan TS005.

Conditions reported: Parkinson Disease; Essential Tremor

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
Phases
NA
Sponsor
Stimvia s.r.o.
Start date reported by registry
2024-07-19 (actual)

Registry updated: 2024-08-26 · Status last verified by the registry submitter: 2024-08

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Lukas Peter, Ph.D. · +420732745185 · peter@stimvia.com

Lukas Doskocil · +420776721127 · doskocil@stimvia.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Cerebrovaskulární poradna s.r.o.

Ostrava, Czechia

Recruiting

David Skoloudik, MD, PhD · +420 739 782 970 · skoloudik@email.cz

Facility not reported

Czechia

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.