Clinical trial NCT06036368: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Essential Tremor
Keywords: Parkinson's Disease (PD) and Essential Tremor (ET)
Peroneal Electrical Transcutaneous NeuroModulation
Lead sponsor: Stimvia s.r.o.
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and tolerability
timeFrame: Baseline to end of treatment at 6 weeks
Secondary outcomes:
measure: Response of the condition on the therapy
timeFrame: Baseline to end of treatment at 6 weeks
Other outcomes:
measure: Exploratory efficacy
timeFrame: Baseline to end of treatment at 6 weeks
measure: Exploratory efficacy
timeFrame: Baseline to end of treatment at 6 weeks
measure: Exploratory efficacy
timeFrame: Baseline to end of treatment at 6 weeks
measure: Exploratory efficacy
timeFrame: Baseline to end of treatment at 6 weeks
measure: Exploratory efficacy
timeFrame: Baseline to end of treatment at 6 weeks
measure: Exploratory efficacy
timeFrame: Baseline to end of treatment at 6 weeks
measure: Exploratory efficacy
timeFrame: Baseline to end of treatment at 6 weeks
measure: Exploratory efficacy
timeFrame: Baseline to end of treatment at 6 weeks
measure: Exploratory efficacy
timeFrame: Baseline to end of treatment at 6 weeks
Locations:
city: Ostrava
country: Czechia
facility: Cerebrovaskulární poradna s.r.o.
Study officials:
affiliation: Cerebrovaskulární poradna s.r.o., Ostrava
name: David Skoloudik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: