Evaluating a new therapy for Parkinson's disease and essential tremor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.