Felix NeuroAI Wristband for Essential Tremor (TRANQUIL Trial)

N/A

Waitlist Available

Research Sponsored by Fasikl Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up continuously measured up to 1 year

Summary

This trial aims to see if the Felix NeuroAI Wristband is a safe and effective treatment for patients with essential tremor. Participants will be given either the Felix device or a sham device for up

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this summary does not provide specific side effects of the Felix NeuroAI Wristband, we can assume that potential side effects will be monitored during the trial as part of assessing its safety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ continuously measured up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~continuously measured up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and continuously measured up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) modified Activities of Daily Living (mADL) score from baseline pre-stimulation to Day 90

Secondary study objectives

Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) modified Activities of Daily Living (mADL) score from baseline pre-stimulation to 14 days, 30 days, 60 days, 180 days, and 1 year

Clinical Global Impression of Improvement (CGI-I)

Clinical Global Impression of Severity (CGI-S)

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