Felix System for Essential Tremor and Parkinson's Disease

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Felix system, a new potential device, to determine its effectiveness in reducing arm tremors for individuals with essential tremor or Parkinson's disease. The goal is to assess whether this system is safe and effective in easing daily life for those with frequent tremors. Ideal participants are adults diagnosed with either essential tremor or Parkinson's disease who have noticeable arm tremors. Participants should be comfortable using a smartphone and connecting to Wi-Fi. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could enhance quality of life for many.

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 prior data suggests that the Felix system is safe for relieving upper limb tremors?

Research shows that the Felix NeuroAI Wristband, part of the Felix System, is under testing to determine its safety and effectiveness in reducing hand and arm tremors. As a pilot study, it primarily assesses basic safety and effectiveness, though specific results are not provided.

Previous studies on similar devices have not revealed major safety issues, suggesting general safety. However, as this research is in its early stages, unknown risks or side effects may still exist.

Participants should discuss potential risks with the research team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Felix System is unique because it introduces a novel approach to managing tremors associated with Essential Tremor and Parkinson's disease. Unlike conventional treatments like medications or deep brain stimulation, which often involve drugs or invasive procedures, the Felix System is a non-invasive technology. Researchers are particularly excited about this system's potential for fewer side effects and its ability to provide targeted relief without the need for surgery or long-term medication use. This could mark a significant advancement in improving the quality of life for patients with these conditions.

What evidence suggests that the Felix system is effective for relieving upper limb tremors in essential tremor and Parkinson's disease?

Studies have shown that the Felix System, which participants in this trial will receive, can help reduce tremors in people with essential tremor and Parkinson's disease. Nearly two-thirds of participants using Felix experienced at least a 20% improvement in their ability to perform daily activities, compared to just one-quarter of those using a fake device. The Felix System uses advanced technology to target and reduce tremors, making everyday tasks easier for users. These results suggest that the Felix System could effectively manage tremors. ^{4 6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Felix System

How Is the Trial Designed?

Group I: Felix Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Fasikl Inc.

Lead Sponsor

Trials

2

Recruited

170+

Citations

1. fasikl.com fasikl.com/fasikl-announces-breakthrough-pivotal-data-demonstrating-superiority-of-felix-neuroai-wristband-over-sham-device-for-essential-tremor-2/

Fasikl Announces Breakthrough Pivotal Data ... Nearly two-thirds of participants using Felix achieved at least a 20% reduction in mADL scores versus just one-quarter in the sham group.

2. memphasys.com memphasys.com/wp-content/uploads/2024/10/2795692.pdf

Memphasys commences Three-Year Equine Fertility Study, ... Felix™ System study has demonstrated significant improvement in fresh stallion sperm quality, positioning it as a leading technology for ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06235190

Study Details | NCT06235190 | Assessment of the Safety ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9840737/

A comparison between the Felix™ electrophoretic system ... The purpose of this publication is to present the first results of a comparative analysis of this Felix™ system in comparison with DGC for the ...

5. neurologylive.com neurologylive.com/view/felix-neuroai-wristband-demonstrates-superiority-over-sham-device-tranquil-study-essential-tremor

Felix NeuroAI Wristband Demonstrates Superiority Over ... Nearly two-thirds of the Felix users achieved at least a 20% reduction in mADL scores, compared with just one-quarter in the sham group.

6. felixnonwovens.com felixnonwovens.com/upload/urunler/dosya/3f741938.pdf

SAFETY DATA SHEET - Felix Nonwovens Explosion hazard: Vapours generated from overheating/melting/decomposition may be flammable and may cause fire/explosion if source of ignition is present.

7. felixhub.com felixhub.com/

Felix Condition Monitoring Reporter- your asset condition ... A simple to implement asset health register, providing a central repository and learning platform for all your condition monitoring assessments and inspections.

8. felix.net felix.net/

Felix: Enterprise Vendor Management Software for Capital ... Seamlessly manage all tiers of your supply chain from vendor relationship, compliance, performance through to sourcing and contracts.

9. felixforyou.ca felixforyou.ca/legal/external-conduct-policy

External Conduct Policy - Felix The Felix Platform is designed to provide real medical care, not for testing the system, misusing services, or engaging in dishonest behavior.