Actively Recruiting
24-months Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
Led by Stimvia s.r.o. · Updated on 2024-08-26
20
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
24-months Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 for 30 days prior to study entry
- Willing to comply with study protocol requirements
- Agrees not to participate in another study from 30 days before baseline until final study visit
- For subjects with Parkinson's disease: bradykinesia and rigidity in "on" period and hand/arm tremor grade 1 in "on" period
- For subjects with Essential Tremor: visible hand/arm and/or foot/leg tremor grade 1
You will not qualify if you...
- Implanted electrical medical device such as pacemaker, defibrillator, or deep brain stimulator
- Suspected or diagnosed epilepsy or seizure disorder
- Clinical signs or diagnosis of dementia
- Swollen, infected, inflamed areas, open wounds, or cancerous skin lesions at stimulation site
- Clinical signs of peripheral neuropathy on lower limbs
- Presence of chorea and/or dyskinesia
- Clinical symptoms or diagnosis of major depressive disorder
- Presence of other neurodegenerative diseases (e.g., multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, Alzheimer's disease)
- Botulinum toxin injection within 6 months before enrollment
- Breastfeeding, pregnant, or intending to become pregnant without reliable birth control
- Unable to communicate effectively with study staff
- Life expectancy less than 6 months
- Active malignant disease
- Conditions posing risk or interfering with study participation
- Poor understanding of or poor compliance with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cerebrovaskulární poradna s.r.o.
Ostrava, Czechia, 70200
Actively Recruiting
Research Team
L
Lukas Peter, Ph.D.
CONTACT
L
Lukas Doskocil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here