Felix System for Essential Tremor and Parkinson's Disease
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.12345Why 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.46789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Felix system for evaluation of safety and effectiveness in relieving upper limb tremors
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Felix System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fasikl Inc.
Lead Sponsor
Citations
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.
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 ...
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 ...
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-tremorFelix 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.
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.
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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.
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