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

• ClinicalTrials.gov Identifier: NCT06036368
• Recruitment Status: Not yet recruiting
• First Posted: September 13, 2023
• Last Update Posted: September 13, 2023
• Sponsor: Stimvia s.r.o.
• Information provided by (Responsible Party): Stimvia s.r.o.

Tracking Information

• First Submitted Date: August 18, 2023
• First Posted Date: September 13, 2023
• Last Update Posted Date: September 13, 2023
• Estimated Study Start Date: September 15, 2023
• Estimated Primary Completion Date: March 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2023)

Safety and tolerability [ Time Frame: Baseline to end of treatment at 6 weeks ]

Incidence of treatment emergent adverse events

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 6, 2023)

Efficacy [ Time Frame: Baseline to end of treatment at 6 weeks ]

Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: September 6, 2023)

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
• 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)
• Brief 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Parkinson's Disease
• Essential 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

Study Arms

Experimental: Peroneal eTNM arm

All patients will receive treatment with peroneal eTNM

Intervention: Device: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 6, 2023): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2024
• Estimated Primary Completion Date: March 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Roman V Dvorak, MD PhD; +420 734 577 837; dvorak@stimvia.com

Contact: Lukas Doskocil; +420 776 721 127; doskocil@stimvia.com

• Listed Location Countries: Czechia

Administrative Information

• NCT Number: NCT06036368
• Other Study ID Numbers: TS004-PD
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Stimvia s.r.o.
• Original Responsible Party: Same as current
• Current Study Sponsor: Stimvia s.r.o.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Stimvia s.r.o.
• Verification Date: September 2023