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

Korábbi kezelés

• Botulinum toxin injection within 6 months prior to study enrollment
• Subject with alcohol (more than 100 mg ethanol per day) or drug abuse during the recruitment and during the trial course

Más betegség

• Suspected or diagnosed epilepsy or other seizure disorder
• 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
• 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.
• 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.
• Subject with active malignant disease

Egyéb

• Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
• Severe degree of disability or dependence in daily activities >grade 3 as measured by modified Rankin Scale (mRS)
• Presence of clinical signs of peripheral neuropathy on lower limbs
• Presence of chorea and/or dyskinesia
• Participation in another interventional clinical trial in the last 30 days, which may confound the results of this study, unless approved by the Sponsor
• Subjects unable to communicate effectively with the investigator and staff
• Life expectancy less than 6 months
• 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

• 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