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

Essential Tremor Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

The TRANQUIL study is a prospective, randomized, sham-controlled, double-blinded, multi-center, multi-region trial. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Felix NeuroAI Wristband to aid in the relief of upper limb tremor in adults with essential tremor (ET). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06235190
Study type Interventional
Source Fasikl Inc.
Contact Head of Clinical Affairs
Phone 1-507-403-7680
Email felixsupport@fasikl.com
Status Recruiting
Phase N/A
Start date February 27, 2024
Completion date November 2025
View Details
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