Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor

Ki vehet részt

• At least 18 years of age
• Willing to provide written, informed consent to participate in the study
• A clinical diagnosis of ET by a movement disorder specialist
• For the dominant hand, a tremor severity score of 2 or higher as measured by one of the TETRAS Performance Subscale (PS) tasks (items 4, 6, 7, and 8) and a total score of 7 or higher across these items. If applicable, this must be met while the patient is on ET treatment
• Stable dosage of anti-tremor medications, if applicable, for 30 days prior to study entry
• Stable dosage of antidepressant medications, if applicable, for 90 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 anti-tremor and antidepressant medications, if applicable, during the course of the study; Do not start any new anti-tremor treatment during the course of the study (except the assigned treatment in the study); Remaining on stable caffeine consumption, if applicable, during the course of the study; No alcohol or marijuana consumption the day before a study visit; Do not share study/device-related information on the internet or with other study patients

Ki nem vehet részt

• Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity
• Prior surgical intervention for ET such as deep brain stimulation or thalamotomy
• Any current drug abuse
• Use of recreational drugs other than marijuana
• Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment
• Moderate to severe alcohol use disorder (AUD) as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) (the presence of at least 4 symptoms or more)
• Current unstable epileptic conditions with a seizure within 6 months of study entry
• Other possible causes of tremor such as drug-induced tremor, enhanced physiological tremor, dystonia, and Parkinson's disease
• Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at the stimulation site
• Known allergy to adhesive bandages
• The presence of any cognitive or other impairment that in the judgement of the investigator will impede the assessment of study outcomes
• History of use of other transcutaneous afferent patterned stimulation (TAPS) devices such as Cala Trio
• Any health condition that in the investigator's opinion should preclude participation in this study
• 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 study staff