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Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor

NCT05842434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-06-25

No results posted yet for this study

Summary

A prospective, open-label, multi-center pilot study designed to evaluate the safety and effectiveness of the Felix system in the relief of upper limb tremors in adults with essential tremor and Parkinson's disease.

Conditions

Interventions

DEVICE

Felix

Felix is a wrist-worn, noninvasive, transcutaneous neurostimulation system intended for daily use to suppress hand tremors. An artificial intelligence (AI) algorithm will automatically adjust the stimulation based on each patient's tremor throughout the day.

Sponsors & Collaborators

  • Fasikl Inc.

    lead INDUSTRY

Principal Investigators

  • Richard B Dewey III, MD · Parkinson's Disease and Movement Disorders Center of Boca Raton

  • Rajesh Pahwa, MD · University of Kansas Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-06
Primary Completion
2023-11-29
Completion
2023-11-29
FDA Device
Yes

Countries

  • United States

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 NCT05842434 on ClinicalTrials.gov