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

Recruiting at 1 trial location

Overseen By Zhen Zhang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fasikl Inc.

Disqualifiers: Peripheral neuropathy, Drug abuse, Epilepsy, Alzheimer's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 week

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. The trial requires that you stay on a stable dosage of your current medications during the study.

What is the purpose of this trial?

This trial is testing the Felix system, a device to reduce arm shaking, in adults with essential tremor and Parkinson's disease.

Research Team

Richard B Dewey III, MD

Principal Investigator

Parkinson's Disease and Movement Disorders Center of Boca Raton

Rajesh Pahwa, MD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with essential tremor (ET) by a doctor.

Willing to provide written, informed consent to participate in the study

For either upper limb, a tremor severity score of 2 or higher as measured by one of the TETRAS items and a total score of 6 or higher across all TETRAS tasks

Exclusion Criteria

Prior electrical medical device implantation (except for pacemaker or implantable cardioverter defibrillator) such as deep brain stimulator, vagus nerve stimulator, responsive neurostimulator, etc.

Pregnant or nursing subjects and those who plan pregnancy during the course of the study

History of Alzheimer's disease or dementia (Montreal Cognitive Assessment (MoCA)≤19)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Felix system for evaluation of safety and effectiveness in relieving upper limb tremors

1 week

Baseline and follow-up visits within 7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Felix System

Participant Groups

Group I: Felix Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Fasikl Inc.

Lead Sponsor

Trials

2

Recruited

170+