Felix NeuroAI Wristband for Essential Tremor

(TRANQUIL Trial)

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

126 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

Is the Felix NeuroAI Wristband safe for humans?

The Felix NeuroAI Wristband, a wearable device for tremor management, has been tested for safety and was found to be safe and well tolerated in a study involving individuals with Parkinson's disease. ^{2 6 7 8 9}

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. ^{1 3 10 11 12}

Eligibility Criteria

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

My anti-tremor medication dose has been the same for the last 30 days.

I am 18 years old or older.

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

Exclusion Criteria

I have had an amputation or I experience nerve pain in my arm.

My tremor is not caused by drugs, stress, dystonia, or Parkinson's disease.

I have had brain surgery for essential tremor.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Rationale and Evidence for Peripheral Nerve Stimulation for Treating Essential Tremor. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Wearable sensors during drawing tasks to measure the severity of essential tremor. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Double-blind controlled trial of gabapentin in essential tremor. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Botulinum Toxin Type A Injections as Monotherapy for Upper Limb Essential Tremor Using Kinematics. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional measurement of essential tremor. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A pilot, double-blind, placebo-controlled trial of pregabalin (Lyrica) in the treatment of essential tremor. [2015]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of a Wearable, Vibrotactile Stimulation Device for Parkinson's Disease. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

New actigraph for long-term tremor recording. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Damping TENS-Induced Essential Tremor Symptoms in Activities of Daily Living Using the TuMove Wrist Exoskeleton. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

A positron emission tomography study of essential tremor: evidence for overactivity of cerebellar connections. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Essential Tremor accentuates the pattern of tremor-band coherence between upper-limb muscles. [2023]