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

NCT06235190 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-03-12

No results posted yet for this study

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.

Conditions

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).

Sponsors & Collaborators

  • Fasikl Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2024-10-31
Completion
2025-11-30
FDA Device
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06235190 on ClinicalTrials.gov