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Behavioural Intervention

Felix NeuroAI Wristband for Essential Tremor (TRANQUIL Trial)

N/A
Recruiting
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
Awards & highlights

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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)
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Felix NeuroAI WristbandExperimental Treatment1 Intervention
Group II: Sham DevicePlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Fasikl Inc.Lead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Essential Tremor
40 Patients Enrolled for Essential Tremor
~45 spots leftby Nov 2024