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

NCT06570421 | Recruiting

• 1 other identifier: TS005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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

Parkinson Disease; Essential Tremor

Keywords

Parkinson Diseases (PD); Essential Tremor (ET); Peroneal Electrical Transcutaneous Neuromodulation; pETNM

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability Assessed by Treatment Emergent Adverse Events

  Safety and tolerability based on all safety data collected in the study, including number and type of treatment emergent adverse events (TRAEs).

  Baseline to end of the treatment (24 months, based on the study protocol)

Secondary Outcomes (1)

• Therapy Response Measured by Patient Global Impression of Improvement (PGI-I) Scale

  Baseline to end of the treatment (24 months, based on the study protocol)

Other Outcomes (8)

• Exploratory endpoints

  Baseline to end of the treatment (24 months, based on the study protocol)

• Exploratory endpoints

  Baseline to end of the treatment (24 months, based on the study protocol)

• Exploratory endpoints

  Baseline to end of the treatment (24 months, based on the study protocol)

Study Arms (1)

Peroneal eTNM arm

EXPERIMENTAL

All patients will receive treatment with peroneal eTNM

Device: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)

Interventions

Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) DEVICE

This is a non-invasive intervention, which utilizes direct transcutaneous, electrical stimulation of the peroneal nerve

Also known as: URIS

Peroneal eTNM arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stimvia s.r.o.: lead

Study Sites (1)

Cerebrovaskulární poradna s.r.o.

Ostrava, 70200, Czechia

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• David Skoloudik, MD, Ph.D.

  Cerebrovaskularni poradna s.r.o.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Peter, Ph.D.

CONTACT

+420732745185; peter@stimvia.com

Lukas Doskocil

CONTACT

+420776721127; doskocil@stimvia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 26, 2024
• Study Start: July 19, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)