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

NCT06036368 | Completed

• 1 other identifier: TS004-PD
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Essential Tremor

Keywords

Parkinson's Disease (PD) and Essential Tremor (ET); Peroneal Electrical Transcutaneous NeuroModulation

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Incidence of treatment emergent adverse events

  Baseline to end of treatment at 6 weeks

Secondary Outcomes (1)

• Response of the condition on the therapy

  Baseline to end of treatment at 6 weeks

Other Outcomes (9)

• Exploratory efficacy

  Baseline to end of treatment at 6 weeks

• Exploratory efficacy

  Baseline to end of treatment at 6 weeks

• Exploratory efficacy

  Baseline to end of treatment at 6 weeks

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 trancutaneous, electrical stimulation of the peroneal nerve

Peroneal eTNM arm

Eligibility Criteria

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

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Stimvia s.r.o.: lead

Study Sites (1)

Cerebrovaskulární poradna s.r.o.

Ostrava, 70200, Czechia

Location

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, PhD

  Cerebrovaskulární poradna s.r.o., Ostrava

  PRINCIPAL INVESTIGATOR

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 18, 2023
• First Posted: September 13, 2023
• Study Start: September 15, 2023
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: August 21, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)