Felix NeuroAI Wristband for Essential Tremor
(TRANQUIL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical study is to compare Felix NeuroAI Wristband and sham device in patients with essential tremor. The main question it aims to answer is:• Is Felix a safe and efficacious treatment for patients with essential tremor?Participants will be treated with either Felix or Sham for a period of up to 90 days. After that, they will be eligible to participate in a long-term, open-label study and be treated with Felix.
Will I have to stop taking my current medications?
You will not have to stop taking your current medications, but you must keep your anti-tremor and antidepressant medication dosages stable during the study. You also cannot start any new anti-tremor treatments while participating.
Is the Felix NeuroAI Wristband safe for humans?
How does the Felix NeuroAI Wristband treatment for essential tremor differ from other treatments?
The Felix NeuroAI Wristband is unique because it likely uses peripheral nerve stimulation, similar to the Cala system, to control arm tremors by delivering high-frequency pulses to the nerves in the wrist. This approach is different from traditional medications or surgical options, as it is non-invasive and specifically targets the nerves involved in tremor generation.678910
What data supports the effectiveness of the Felix NeuroAI Wristband treatment for essential tremor?
The Cala system, a similar wrist-worn device, has been recognized for its ability to control arm tremors in essential tremor by stimulating peripheral nerves with high-frequency pulses. This suggests that the Felix NeuroAI Wristband, which likely uses a similar approach, may also be effective in managing essential tremor symptoms.1671112
Are You a Good Fit for This Trial?
This trial is for adults with essential tremor, diagnosed by a specialist. Participants must have a certain level of hand tremor severity and be on stable medication doses if they're taking anti-tremor or antidepressant drugs. They should know how to use a smartphone and Wi-Fi, and may need a caregiver's help for study activities.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are treated with either Felix NeuroAI Wristband or sham device for a period of up to 90 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may opt into a long-term study and be treated with Felix
What Are the Treatments Tested in This Trial?
Interventions
- Felix NeuroAI Wristband
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fasikl Inc.
Lead Sponsor