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

6-weeks, Open-label, Single-Site Study to Evaluate Safety, Tolerability and Efficacy of the Home-based Peroneal Electrical Transcutaneous NeuroModulation (Peroneal eTNM®) Treatment Via Nerve Stimulator URIS ITM in Treatment of Symptoms Related to Movement Disorders in Subjects With Parkinson's Disease (PD) and Essential Tremor (ET)

This is a 6-week exploratory clinical study, designed to test whether treatment with peroneal electrical trans-cutaneous stimulation can have a beneficial effects on symptoms associated with Parkinson's diseases and essential tremor.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease; Essential Tremor
• Intervention / Treatment: Device: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)

Detailed Description

This is a 6-week, open-label, single site clinical study designed to test whether treatment with peroneal electrical trans-cutaneous stimulation (eTNM) can have a beneficial effects on symptoms associated with Parkinson's diseases (PD) and essential tremor (ET). Eligible patients will be treated with eTNM at home for 6 weeks. Primary endpoint in this study is tolerability and safety, secondary and exploratory endpoints are various scale designed to capture improvements in the most bothersome symptoms of PD or ET.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Ostrava, Czechia, 70200
    • Cerebrovaskularni poradna s.r.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age
• 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 screening 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
• Severe degree of disability or dependence in daily activities >grade 3 as measured by modified Rankin Scale (mRS)
• 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
• Participation in another interventional clinical trial in the last 30 days, which may confound the results of this study, unless approved by the Sponsor
• 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 both Visits 1 and 2 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 with alcohol (more than 100 mg ethanol per day) or drug abuse during the recruitment and during the trial course
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peroneal eTNM arm; All patients will receive treatment with peroneal eTNM	Device: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®); This is a non-invasive intervention, which utilizes direct trancutaneous, electrical stimulation of the peroneal nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Incidence of treatment emergent adverse events	Baseline to end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response of the condition on the therapy	Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better)	Baseline to end of treatment at 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory efficacy	The Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score (both total score and subscores) (applicable only for subjects with PD)(0-260, lower score = better)	Baseline to end of treatment at 6 weeks
Exploratory efficacy	Essential tremor rating assessment scale (TETRAS) score (applicable only for subjects with ET, 0-64, lower scores = better))	Baseline to end of treatment at 6 weeks
Exploratory efficacy	Bradykinesis and rigidity measured by Five Times Sit to Stand Test (FTSTS) (applicable only for subjects with PD, time in seconds, lower = better))	Baseline to end of treatment at 6 weeks
Exploratory efficacy	Bradykinesis and rigidity measured objectively using the 10 meter Walking Speed Test (WST) (time in seconds, lower = better)(applicable only for subjects with PD)	Baseline to end of treatment at 6 weeks
Exploratory efficacy	Effect on patient's daily activities measured by Bain and Findley Activities of Daily Living (BF-ADL) (25-100, lower score = better)	Baseline to end of treatment at 6 weeks
Exploratory efficacy	Degree of disability measured by modified Rankin Scale (mRS) (0-6, lower score= better)	Baseline to end of treatment at 6 weeks
Exploratory efficacy	Quality of life measured by European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L)(0.532-1.000, higher score = better)	Baseline to end of treatment at 6 weeks
Exploratory efficacy	Disease-specific quality of life measured by Parkinson's Disease Questionnaire (PDQ -39)(0-100, lower score = better)	Baseline to end of treatment at 6 weeks
Exploratory efficacy	Patient's satisfaction using Treatment Satisfaction Visual Analog scale (TS-VAS)(0-100, higher score = better)	Baseline to end of treatment at 6 weeks

Collaborators and Investigators

• Sponsor: Stimvia s.r.o.
• Investigators: Principal Investigator: David Skoloudik, MD, PhD, Cerebrovaskulární poradna s.r.o., Ostrava

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Parkinson's Disease (PD) and Essential Tremor (ET); Peroneal Electrical Transcutaneous NeuroModulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Parkinson Disease; Tremor; Essential Tremor
• Other Study ID Numbers: TS004-PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No