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

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.

Eligibility

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

Conditions3

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