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

Stimvia

Status

Completed

Conditions

Essential Tremor

Parkinson's Disease

Treatments

Device: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06036368

TS004-PD

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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