Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor

NCT06235190 | Active Not Recruiting FDA Device

• 1 other identifier: FSK-CIP-2
• Study Type: interventional
• Target: 126
• Locations: 2 countries
• Sites: 12

Brief Summary

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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) modified Activities of Daily Living (mADL) score from baseline pre-stimulation to Day 90

  TETRAS mADL score is a composite sum of items 2 to 11 of the TETRAS ADL subscale and items 6 (bilateral) and 7 (dominant hand) of the TETRAS performance subscale (PS). Each item is scored from 0 to 4, indicating increasing severity of tremor. TETRAS mADL score is calculated as the sum of all 12 items and ranges from 0 to 52.

  90 days

Secondary Outcomes (12)

• Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) modified Activities of Daily Living (mADL) score from baseline pre-stimulation to 14 days, 30 days, 60 days, 180 days, and 1 year

  14 days, 30 days, and 60 days, 180 days, and 1 year

• Responder Rate

  14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.

• Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Items 1, 4, and 8

  Baseline, 30 days, 90 days, and 1 year

• Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Items 6 and 7

  Baseline,14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.

• Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Dominant Hand Score

  Baseline, 30 days, 90 days, and 1 year

Study Arms (2)

Felix NeuroAI Wristband

EXPERIMENTAL

Device: Felix NeuroAI Wristband

Sham Device

SHAM COMPARATOR

Device: Sham Device

Interventions

Felix NeuroAI Wristband DEVICE

The Felix NeuroAI Wristband (Felix) is a wrist-worn, noninvasive, transcutaneous neurostimulation system. Using a proprietary artificial intelligence (AI) algorithm, stimulation will be automatically adapted to patient's needs with the goal to provide full day relief of upper limb tremor.

Felix NeuroAI Wristband

Sham Device DEVICE

The sham device has the same exterior appearance and components as the Felix device and is used the same way (without delivering the treatment).

Sham Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Willing to provide written, informed consent to participate in the study.
• A clinical diagnosis of ET by a movement disorder specialist.
• For the dominant hand, a tremor severity score of 2 or higher as measured by one of the TETRAS Performance Subscale (PS) tasks (items 4, 6, 7, and 8) and a total score of 7 or higher across these items. If applicable, this must be met while the patient is on ET treatment.
• Stable dosage of anti-tremor medications, if applicable, for 30 days prior to study entry.
• Stable dosage of antidepressant medications, if applicable, for 90 days prior to study entry.
• Familiar with operating a touch-screen smartphone and connecting to Wi-Fi internet at home.
• If necessary, have a dedicated caregiver to help with study required activities, such as putting on the study device, etc.
• Willing to comply with study protocol requirements including:
• Remaining on a stable dosage of anti-tremor and antidepressant medications, if applicable, during the course of the study.
• Do not start any new anti-tremor treatment during the course of the study (except the assigned treatment in the study).
• Remaining on stable caffeine consumption, if applicable, during the course of the study.
• No alcohol or marijuana consumption the day before a study visit.
• Do not share study/device-related information on the internet or with other study patients.

You may not qualify if:

• Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity.
• Prior surgical intervention for ET such as deep brain stimulation or thalamotomy.
• 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.
• Use of recreational drugs other than marijuana.
• Current unstable epileptic conditions with a seizure within 6 months of study entry.
• Other possible causes of tremor such as drug-induced tremor, enhanced physiological tremor, dystonia, and Parkinson's disease.
• Pregnant or nursing subjects and those who plan pregnancy during the course of the study.
• Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at the stimulation site.
• Known allergy to adhesive bandages.
• The presence of any cognitive or other impairment that in the judgement of the investigator will impede the assessment of study outcomes.
• Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment.
• History of use of other transcutaneous afferent patterned stimulation (TAPS) devices such as Cala Trio.
• Subject is currently participating or has participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor.
• Subject is unable to communicate with the investigator and study staff.

Sponsors & Collaborators

• Fasikl Inc.: lead

Study Sites (12)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, 94301, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

The University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Parkinson's Research Centers of America - Long Island

Commack, New York, 11725, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

Xuanwu Hospital Capital Medical University

Beijing, 100053, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Related Publications (1)

• Ondo WG, Lv W, Zhu X, Hu Y, Isaacson SH, Yuan Y, Espay AJ, Kreitzman D, Kuo SH, Brillman S, Shill HA, Lyons KE, Yang Z, Zhao Q, Zhang Z, Pahwa R. Transcutaneous Peripheral Nerve Stimulation for Essential Tremor: A Randomized Clinical Trial. JAMA Neurol. 2025 Dec 1;82(12):1235-1242. doi: 10.1001/jamaneurol.2025.3905.

  PMID: 41114984 DERIVED

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in a 2:1 ratio to Felix and Sham and be followed for 90 days. After the 90-day follow-up, all subjects will be encouraged to participate in the continued access phase, where subjects randomized to the Sham arm will cross over to Felix and all subjects will be followed up to 1 year (from randomization).

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 31, 2024
• Study Start: February 27, 2024
• Primary Completion: October 31, 2024
• Study Completion: November 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); CN (4)