Home Use Study of Targeted Mechanical Stimulation for Tremor Relief

Inclusion Criteria - Alpha and Beta Phase B1

• Age 18 years or older, able to comply with all study procedures and capable of providing informed consent.
• Mentally competent to understand and able to perform written, informed consent to participate in the study
• A diagnosis of either ET or PD as determined by clinical history
• Moderate to severe upper limb tremor

Exclusion Criteria - Alpha and Beta Phase B1

• Pregnant women
• Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
• History of psoriasis, eczema or atopic dermatitis at the stimulation site
• History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and diabetic neuropathy
• Participant unable to communicate with sponsor/investigator and staff
• Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject unsuitable as a candidate for the study.

Inclusion Criteria - Beta Phase B2

• Age 18 years or older, able to comply with all study procedures and capable of providing informed consent
• Mentally competent to understand and able to perform written, informed consent to participate in the study
• For ET subjects, a diagnosis of essential tremor defined as definite or probable ET based on TRIG criteria
• For PD subjects, a diagnosis of Parkinson's disease by a Movement Disorder Specialist
• For ET subjects, at least one hand exhibiting tremor > 2 as assessed by the Essential Tremor Rating Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit
• For PD subjects, a score > 2 on at least one of MDS-UPDRS items 3.15, 3.16 or 3.17 At the Screening Visit, a score of > 3 on one of the following subject-assessed items of the Bain \& Findley Activities of Daily Living Scale (BF-ADL): Use a spoon to drink soup, Hold a cup of tea, Do up buttons, Do up a zipper, Write a letter
• Stable medications for at least 30 days prior to enrollment and the ability to maintain tremor medications throughout the duration of study participation
• For PD subjects, able to participate in visits in a practically defined OFF state (withdrawal from all tremor medication for 12 hours prior to study visits)
• A wrist circumference of 6.0 - 8.1 inches

Exclusion Criteria - Beta Phase B2

• Pregnant women
• Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
• History of psoriasis, eczema or atopic dermatitis at the stimulation site
• History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and -diabetic neuropathy
• Participant unable to communicate with sponsor/investigator and staff
• Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject unsuitable as a candidate for the study