Actively Recruiting
24-month Open-label Study to Evaluate Safety, Tolerability, and Efficacy of Home-based Peroneal Electrical Transcutaneous NeuroModulation Using URIS ITM in Parkinson's Disease and Essential Tremor
Led by Stimvia s.r.o. · Updated on 2024-08-26
20
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the long-term safety, tolerability, and effectiveness of a home-based peroneal electrical transcutaneous neuromodulation (eTNM4) treatment using the URIS I12 device in people with Parkinson's disease (PD) or Essential Tremor (ET). Earlier, a 6-week pilot study with 24 participants showed that this home treatment was safe, well tolerated, and had high adherence, with no treatment-related side effects. Although not designed to prove effectiveness, the pilot suggested improvements in tremor symptoms that lasted for weeks after treatment ended. This extension study aims to further evaluate these outcomes over a longer period. All participants will receive the peroneal eTNM treatment using the URIS I12 neurostimulator device. This device delivers electrical stimulation directly through the skin to the peroneal nerve. The study follows the same treatment procedure as previous studies but applies it over a longer timeframe to assess ongoing effects. This is an open-label, single-site study lasting 24 months, during which participants will continue home-based therapy under the study protocol. Participants will be monitored for safety and tolerability throughout the 24-month treatment period, with particular attention to any adverse events related to the therapy. Effectiveness will be assessed using patient self-reports and clinical scales measuring tremor severity and motor function. Researchers will also track participants' adherence and overall experience with the home treatment. The study aims to provide comprehensive data on the long-term impact of this non-invasive neuromodulation therapy on symptoms related to movement disorders in PD and ET.
CONDITIONS
Brief 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, if applicable
- Willing to comply with study protocol requirements
- Agrees not to participate in another study from 30 days prior to baseline until final study visit
- For Parkinson's disease patients: bradykinesia and rigidity in "on" period based on clinical assessment
- For Parkinson's disease patients: hand/arm tremor (resting, intentional, or postural) grade 1 or higher as assessed by MDS-UPDRS tremor score in "on" period
- For Essential Tremor patients: visible hand/arm and/or foot/leg tremor grade 1 or higher as assessed by TETRAS
You will not qualify if you...
- Implanted electrical medical device such as pacemaker, defibrillator, or deep brain stimulator
- Suspected or diagnosed epilepsy or other 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
- Any other neurodegenerative disease such as multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, or Alzheimer's disease
- Botulinum toxin injection within 6 months prior to enrollment
- Pregnant, breastfeeding, intending pregnancy during study, or sexually active without highly reliable birth control
- Unable to communicate effectively with study staff
- Life expectancy less than 6 months
- Active malignant disease
- Any condition that may interfere with participation or pose risk as judged by physician
- Poor understanding of the study or likely poor compliance with protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants receive home-based peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) using the URIS I™ device to manage symptoms related to Parkinson's disease or Essential Tremor.
Regular visits as scheduled during the 24 months treatment period
Trial Site Locations
Total: 1 location
1
Cerebrovaskulární poradna s.r.o.
Ostrava, Czechia, 70200
Actively Recruiting
Research Team
L
Lukas Peter, Ph.D.
L
Lukas Doskocil
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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