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Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor
Sponsor: Fasikl Inc.
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.
Official title: Assessment of a Novel NeuroAI-powered Transcutaneous Neuromodulation Device in Alleviating Tremor Symptoms and Enhancing Quality of Life for Patients with Upper Limb Essential Tremor
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2024-02-27
Completion Date
2025-11
Last Updated
2025-03-12
Healthy Volunteers
No
Conditions
Interventions
Felix NeuroAI Wristband
The Felix NeuroAI Wristband (Felix) is a wrist-worn, noninvasive, transcutaneous neurostimulation system. Using a proprietary artificial intelligence (AI) algorithm, stimulation will be automatically adapted to patient's needs with the goal to provide full day relief of upper limb tremor.
Sham Device
The sham device has the same exterior appearance and components as the Felix device and is used the same way (without delivering the treatment).
Locations (12)
Barrow Neurological Institute
Phoenix, Arizona, United States
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
The University Of Kansas Medical Center
Kansas City, Kansas, United States
Parkinson's Research Centers of America - Long Island
Commack, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Houston Methodist Research Institute
Houston, Texas, United States
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Xuanwu Hospital Capital Medical University
Beijing, China
Tianjin Medical University General Hospital
Tianjin, China