Status:
RECRUITING
24-months Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
Lead Sponsor:
Stimvia s.r.o.
Conditions:
Parkinson Disease
Essential Tremor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
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 pero...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06570421
Start Date
July 19 2024
End Date
December 1 2026
Last Update
August 26 2024
Active Locations (1)
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1
Cerebrovaskulární poradna s.r.o.
Ostrava, Czechia, 70200