Active — Not RecruitingNot Applicable

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

United States126 participantsStarted 2024-02-27

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Remaining on a stable dosage of anti-tremor and antidepressant medications, if applicable, during the course of the study.
✓. Do not start any new anti-tremor treatment during the course of the study (except the assigned treatment in the study).
✓. Remaining on stable caffeine consumption, if applicable, during the course of the study.
✓. No alcohol or marijuana consumption the day before a study visit.
✓. Do not share study/device-related information on the internet or with other study patients.

What they're measuring

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

Timeframe: 90 days

Trial details

NCT IDNCT06235190

SponsorFasikl Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Essential Tremor trials