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

Parkinson's Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06036368
• Other study ID #: TS004-PD
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Stimvia s.r.o.
• Contact: Roman V Dvorak, MD PhD
• Phone: +420 734 577 837
• Email: dvorak[@]stimvia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Parkinson's Disease
• Tremor

Intervention

Device:
• Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
This is a non-invasive intervention, which utilizes direct trancutaneous, electrical stimulation of the peroneal nerve

Locations

Country	Name	City	State
Czechia	Cerebrovaskulární poradna s.r.o.	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
Stimvia s.r.o.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Exploratory efficacy	Degree of disability measured by modified Rankin Scale (mRS) (0-6, lower score= better)	Baseline to end of treatment at 6 weeks
Other	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
Other	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
Other	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
Primary	Safety and tolerability	Incidence of treatment emergent adverse events	Baseline to end of treatment at 6 weeks
Secondary	Efficacy	Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better)	Baseline to end of treatment at 6 weeks