CompletedNot Applicable

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

United States38 participantsStarted 2023-06-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At least 18 years of age.
. Willing to provide written, informed consent to participate in the study.
. For subjects with essential tremor (ET):
. A clinical diagnosis of ET.
. 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.
. For subjects with Parkinson's disease (PD):
. A clinical diagnosis of PD (MDS-PD criteria).
. A tremor score of 2 or higher on MDS-UPDRS question 3.15 (postural tremor) or 3.16 (kinetic tremor), OR

Exclusion criteria

. Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity.
. Any current drug or alcohol abuse.
. Current unstable epileptic conditions with a seizure within 6 months of study entry.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Performance Subscale

Timeframe: Baseline to 7 days

Trial details

NCT IDNCT05842434

SponsorFasikl Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-29

Results submitted2026-04-03

View on ClinicalTrials.gov More Essential Tremor trials