Felix NeuroAI Wristband for Essential Tremor
(TRANQUIL Trial)
Recruiting at 11 trial 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
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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.
See 13 more
Treatment Details
Interventions
- Felix NeuroAI Wristband (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Felix NeuroAI WristbandExperimental Treatment1 Intervention
Group II: Sham DevicePlacebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fasikl Inc.
Lead Sponsor
Trials
2
Recruited
170+