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

Not Applicable

Active, not recruiting

• Conditions: Essential Tremor
• Interventions: Device: Felix NeuroAI Wristband; Device: Sham Device

• Registration Number: NCT06235190
• Lead Sponsor: Fasikl Inc.

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.

Detailed Description

The TRANQUIL study is a prospective, randomized, sham-controlled, double-blinded, multi-center, multi-region trial. 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 tremor in adults with essential tremor (ET).

Study Timeline

• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-31
• Study Start: 2024-02-27
• Primary Completion: 2024-10-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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:

  1. Remaining on a stable dosage of anti-tremor and antidepressant medications, if applicable, during the course of the study.
  2. Do not start any new anti-tremor treatment during the course of the study (except the assigned treatment in the study).
  3. Remaining on stable caffeine consumption, if applicable, during the course of the study.
  4. No alcohol or marijuana consumption the day before a study visit.
  5. Do not share study/device-related information on the internet or with other study patients.

Exclusion Criteria

• 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.
• Any health condition that in the investigator's opinion should preclude participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Felix NeuroAI Wristband	Felix NeuroAI Wristband	-
Sham Device	Sham Device	-

Primary Outcome Measures

Name	Time	Method
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	90 days	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.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Severity (PGI-S)	Baseline, 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.	Patient rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
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	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.
Responder Rate	14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.	Responder rate is defined as the proportion of patients responding to the treatment, as defined by change in TETRAS mADL score at or above a pre-specified margin.
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	Each TETRAS PS item is scored by physician from 0 to 4, indicating increasing severity of tremor.
Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Dominant Hand Score	Baseline, 30 days, 90 days, and 1 year	The sum of TETRAS PS items 4, 6, 7, and 8 for the dominant hand. Each item is scored by physician from 0 to 4, indicating increasing severity of tremor.
Clinical Global Impression of Severity (CGI-S)	Baseline, 30 days, 90 days, and 1 year	Physician rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
Clinical Global Impression of Improvement (CGI-I)	Baseline, 30 days, 90 days, and 1 year	Physician rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
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.	Each TETRAS PS item is scored by physician from 0 to 4, indicating increasing severity of tremor.
Patient Global Impression of Improvement (PGI-I)	Baseline, 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.	Patient rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
Quality of Life in Essential Tremor Questionnaire (QUEST)	Baseline, 90 days, and 1 year	QUEST is a 30-item scale developed specifically for patients with essential tremor to measure items impacting perceived quality of life (QOL) that generic QOL measures do not effectively capture, including activities of daily living that are affected by essential tremor.
Tremor power	Continuously measured up to 1 year	Device measured tremor power. Unit: (m/s\^2)\^2
Patient survey	14 days, 30 days, 60 days, 90 days, 180 days, and 1 year	Patient survey of satisfaction with the treatment and the durability of the treatment effect

Trial Locations

Locations (12)

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

Parkinson's Research Centers of America - Palo Alto; 🇺🇸 Palo Alto, California, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

The University Of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Parkinson's Research Centers of America - Long Island; 🇺🇸 Commack, New York, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China