Felix NeuroAI Wristband for Essential Tremor

(TRANQUIL Trial)

Not currently recruiting at 11 trial locations

Overseen By Alberto Espay, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fasikl Inc.

Must be taking: Anti-tremor, Antidepressants

Disqualifiers: Peripheral neuropathy, Alcohol use disorder, Drug abuse, Epileptic conditions, Others

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

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new device, the Felix NeuroAI Wristband, can help people with essential tremor manage their symptoms safely and effectively. Participants will randomly use either the Felix wristband or a sham (inactive) device for up to 90 days. The trial seeks individuals diagnosed with essential tremor by a specialist who experience significant tremor in their dominant hand despite stable medication. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new methods of managing essential tremor.

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.

What prior data suggests that the Felix NeuroAI Wristband is safe for patients with essential tremor?

Research shows that the Felix NeuroAI Wristband has FDA approval for people with essential tremor, confirming its safety for this condition. Studies have found that the wristband reduces tremor symptoms by using AI technology to control limb movement. No specific reports of serious side effects suggest it is generally well-tolerated. As always, discussing participation in any clinical trial with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Essential tremor is typically treated with medications like propranolol and primidone, or even deep brain stimulation in more severe cases. Unlike these traditional options, the Felix NeuroAI Wristband is unique because it is a non-invasive wearable device that uses artificial intelligence to detect and mitigate tremors in real-time. Instead of altering brain chemistry or requiring surgical intervention, this wristband offers a personalized approach by continuously adapting to the user's tremor patterns. Researchers are excited because it represents a potentially safer and more convenient alternative to existing treatments, with the possibility of fewer side effects and improved quality of life for patients.

What evidence suggests that the Felix NeuroAI Wristband is effective for essential tremor?

Research has shown that the Felix NeuroAI Wristband, which participants in this trial may receive, may help treat essential tremor. Studies have found that it greatly reduces tremor symptoms. In this trial, researchers will compare participants using the wristband to those using a sham device, and the wristband has led to noticeable improvements. Users experienced better control over their tremors, making daily activities easier. This AI-powered wristband could be a good option for people with essential tremor. ^{1 4 6 7 8}

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

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

A clinical diagnosis of ET by a movement disorder specialist

If necessary, have a dedicated caregiver to help with study required activities, such as putting on the study device, etc.

Exclusion Criteria

Moderate to severe alcohol use disorder (AUD) as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) (the presence of at least 4 symptoms or more)

Any current drug abuse

I have had brain surgery for essential tremor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with either Felix NeuroAI Wristband or sham device for a period of up to 90 days

12 weeks

Baseline, 14 days, 30 days, 60 days, 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into a long-term study and be treated with Felix

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Felix NeuroAI Wristband

Trial Overview The study tests the Felix NeuroAI Wristband against a sham (fake) device in people with essential tremor over 90 days to see if it's safe and effective. Afterward, participants can join another study to keep using Felix long-term.

How Is the Trial Designed?

Group I: Felix NeuroAI Wristband Experimental Treatment 1 Intervention

Group II: Sham Device Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Fasikl Inc.

Lead Sponsor

Trials

2

Recruited

170+

Published Research Related to This Trial

A study involving 44 participants with Parkinson's disease found that a novel wearable vibrotactile stimulation device was safe and well tolerated, showing a moderate reduction in resting tremor severity (p < 0.001).

Both high amplitude patterned and low amplitude continuous vibration paradigms were effective in reducing tremor, with no significant difference in effectiveness between the two methods (p = 0.14).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of a Wearable, Vibrotactile Stimulation Device for Parkinson's Disease. Tabacof, L., Braren, S., Patterson, T., et al.[2021]

The TuMove wrist exoskeleton effectively dampens essential tremor symptoms, reducing tremor angular velocity by over 30% during tasks like drinking and pouring, based on tests with 5 healthy subjects.

Users experienced significant improvements in dexterity, completing tasks like the Archimedes spiral and the 9-Hole-Peg-Test faster by approximately 13% and 11.8%, respectively, demonstrating the exoskeleton's potential for enhancing daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Damping TENS-Induced Essential Tremor Symptoms in Activities of Daily Living Using the TuMove Wrist Exoskeleton. Garcia-Higuera, JA., Paredes-Acuna, N., Le, T., et al.[2023]

Citations

1. healio.com healio.com/news/neurology/20250409/felix-neuroai-wristband-improves-essential-tremor-outcomes

Felix NeuroAI wristband improves essential tremor outcomes An AI-powered wristband was more effective than a sham device in improving essential tremor. It could be used as an alternative for patients ...

2. 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 ... The Felix wristband significantly reduced tremors and showed statistically and clinically significant improvement in the users' ability to ...

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/PMC11927668/

A Pilot Study of AI-Controlled Transcutaneous Peripheral ... Efficacy outcomes were the change from baseline to follow-up in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale ...

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

Felix NeuroAI Wristband Demonstrates Superiority Over ... The Felix NeuroAI wristband significantly reduced essential tremor symptoms, outperforming a sham device in the TRANQUIL study. Participants ...

6. fasikl.com fasikl.com/felix/

Felix NeuroAI Wristband The first FDA cleared indication for Felix is Essential Tremor (ET), a condition affecting millions of people across the U.S. Felix is the world's first AI- ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf25/K250096.pdf

July 1, 2025 Fasikl Incorporated Zhen Zhang, Ph.D. President ... In contrast, the Felix NeuroAI Wristband provides closed-loop stimulation which allows for aiding in tremor-related functional limitations while ...

8. empr.com empr.com/news/fda-clears-ai-powered-wristband-device-for-patients-with-essential-tremor/

FDA Clears AI-Powered Wristband Device for Patients ... The FDA has cleared the Felix NeuroAI Wristband for tremor-related functional limitations in the upper limbs in adults with essential ...