Evaluating a new therapy for Parkinson's disease and essential tremor
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)
This study is testing a new home therapy using a special device to see if it can safely help people with Parkinson's disease or essential tremor reduce their tremors over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stimvia s.r.o. Industry-sponsored |
| Locations | 1 site (Ostrava) |
| Trial ID | NCT06570421 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term safety and efficacy of a home-based peroneal electrical transcutaneous neuromodulation therapy using the URIS I™ device in patients with Parkinson's disease or essential tremor. Following a successful pilot study that demonstrated safety and high adherence rates, this extension study aims to further assess the treatment's tolerability and potential benefits on tremor symptoms over a 24-month period. Participants will self-administer the therapy at home, allowing for a more convenient treatment approach.
Who should consider this trial
Good fit: Ideal candidates include individuals with Parkinson's disease or essential tremor who have completed a prior related study and meet specific clinical criteria.
Not a fit: Patients with implanted electrical medical devices or those with certain contraindications may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could provide significant relief from tremor symptoms for patients with Parkinson's disease and essential tremor.
How similar studies have performed: Previous studies on peroneal electrical neuromodulation have shown promising safety and tolerability, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Ostrava
- Cerebrovaskulární poradna s.r.o. — Ostrava, Czechia (Recruiting)
Study contacts
- Principal investigator: David Skoloudik, MD, Ph.D. — Cerebrovaskularni poradna s.r.o.
- Study coordinator: Lukas Peter, Ph.D.
- Email: peter@stimvia.com
- Phone: +420732745185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.