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ACTIVE NOT RECRUITING
NCT06235190
NA

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

Sponsor: Fasikl Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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