Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor

Korábbi kezelés

• Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity.
• Any current drug or alcohol abuse.
• Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment.

Más betegség

• Current unstable epileptic conditions with a seizure within 6 months of study entry.
• Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at the stimulation site.
• Known allergy to adhesives.
• History of Alzheimer's disease or dementia (Montreal Cognitive Assessment (MoCA)≤19).
• Any health condition that in the investigator's opinion should preclude participation in this study.

Egyéb

• Pregnant or nursing subjects and those who plan pregnancy during the course of the study.
• Subject is currently participating or has participated 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 unable to communicate with the investigator and staff.

• At least 18 years of age.
• Willing to provide written, informed consent to participate in the study.
• For subjects with essential tremor (ET):
  • A clinical diagnosis of ET.
  • For either upper limb, a tremor severity score of 2 or higher as measured by one of the TETRAS items and a total score of 6 or higher across all TETRAS tasks.
• For subjects with Parkinson's disease (PD):
  • A clinical diagnosis of PD (MDS-PD criteria).
  • A tremor score of 2 or higher on MDS-UPDRS question 3.15 (postural tremor) or 3.16 (kinetic tremor), OR
  • A rest tremor score of 2 or higher on MDS-UPDRS question 3.17 (rest tremor amplitude) in one upper extremity and a score of 2 or higher on MDS-UPDRS question 3.18 (constancy of tremor).
• Stable dosage of any medication, if applicable, for 30 days prior to study entry.
• Familiar with operating a touch-screen smartphone and connecting to Wi-Fi internet at home.
• If necessary, have a dedicated caregiver to help with study required activities, such as putting on the study device, etc.
• Willing to comply with study protocol requirements including:
  • Remaining on a stable dosage of current medications, if applicable, during the course of the study.
  • Remaining on stable caffeine consumption, if applicable, during the course of t the study.
  • No alcohol consumption on the day before a study visit.