Trials / Active Not Recruiting
Active Not RecruitingNCT06235190
Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 126 (actual)
- Sponsor
- Fasikl Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2024-02-27
- Primary completion
- 2024-10-31
- Completion
- 2025-11-01
- First posted
- 2024-01-31
- Last updated
- 2025-03-12
Locations
12 sites across 2 countries: United States, China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06235190. Inclusion in this directory is not an endorsement.