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

Inclusion Criteria:

• 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 ofthe TETRAS Performance Subscale (PS) tasks (items 4, 6, 7, and 8) and a total scoreof 7 or higher across these items. If applicable, this must be met while the patientis on ET treatment.

• Stable dosage of anti-tremor medications, if applicable, for 30 days prior to studyentry.

• Stable dosage of antidepressant medications, if applicable, for 90 days prior tostudy entry.

• Familiar with operating a touch-screen smartphone and connecting to Wi-Fi internetat 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:

1. Remaining on a stable dosage of anti-tremor and antidepressant medications, ifapplicable, during the course of the study.

2. Do not start any new anti-tremor treatment during the course of the study (except the assigned treatment in the study).

3. Remaining on stable caffeine consumption, if applicable, during the course ofthe study.

4. No alcohol or marijuana consumption the day before a study visit.

5. Do not share study/device-related information on the internet or with otherstudy patients.

Exclusion Criteria:

• Prior limb amputation or any known symptomatic peripheral neuropathy condition ofthe involved upper extremity.

• Prior surgical intervention for ET such as deep brain stimulation or thalamotomy.

• Moderate to severe alcohol use disorder (AUD) as per Diagnostic and StatisticalManual of Mental Disorders Fifth Edition (DSM-5) (the presence of at least 4symptoms or more).

• Any current drug abuse.

• Use of recreational drugs other than marijuana.

• Current unstable epileptic conditions with a seizure within 6 months of study entry.

• Other possible causes of tremor such as drug-induced tremor, enhanced physiologicaltremor, dystonia, and Parkinson's disease.

• Pregnant or nursing subjects and those who plan pregnancy during the course of thestudy.

• Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerouslesions of skin at the stimulation site.

• Known allergy to adhesive bandages.

• The presence of any cognitive or other impairment that in the judgement of theinvestigator will impede the assessment of study outcomes.

• Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment.

• History of use of other transcutaneous afferent patterned stimulation (TAPS) devicessuch as Cala Trio.

• Subject is currently participating or has participated in another interventionalclinical 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.

• Any health condition that in the investigator's opinion should precludeparticipation in this study.