Felix NeuroAI Wristband for Essential Tremor
(TRANQUIL Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Fasikl Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this clinical study is to compare Felix NeuroAI Wristband and sham device in patients with essential tremor. The main question it aims to answer is: • Is Felix a safe and efficacious treatment for patients with essential tremor? Participants will be treated with either Felix or Sham for a period of up to 90 days. After that, they will be eligible to participate in a long-term, open-label study and be treated with Felix.

Eligibility Criteria

This trial is for adults with essential tremor, diagnosed by a specialist. Participants must have a certain level of hand tremor severity and be on stable medication doses if they're taking anti-tremor or antidepressant drugs. They should know how to use a smartphone and Wi-Fi, and may need a caregiver's help for study activities.

Inclusion Criteria

My anti-tremor medication dose has been the same for the last 30 days.

I am 18 years old or older.

Willing to provide written, informed consent to participate in the study

+10 more

Exclusion Criteria

I have had an amputation or I experience nerve pain in my arm.

My tremor is not caused by drugs, stress, dystonia, or Parkinson's disease.

I have had brain surgery for essential tremor.

+13 more

Participant Groups

The study tests the Felix NeuroAI Wristband against a sham (fake) device in people with essential tremor over 90 days to see if it's safe and effective. Afterward, participants can join another study to keep using Felix long-term.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Felix NeuroAI WristbandExperimental Treatment1 Intervention

Group II: Sham DevicePlacebo Group1 Intervention