Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
Parkinson's Disease, Essential Tremor
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease (PD) and Essential Tremor (ET), Peroneal Electrical Transcutaneous NeuroModulation
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
Sites / Locations
- Cerebrovaskulární poradna s.r.o.
Arms of the Study
Arm 1
Experimental
Peroneal eTNM arm
All patients will receive treatment with peroneal eTNM