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

Essential Tremor Clinical Trial

— TRANQUIL  

Official title:

Assessment of a Novel NeuroAI-powered Transcutaneous Neuromodulation Device in Alleviating Tremor Symptoms and Enhancing Quality of Life for Patients With Upper Limb Essential Tremor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235190
• Other study ID #: FSK-CIP-2
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: Fasikl Inc.
• Contact: Head of Clinical Affairs
• Phone: 1-507-403-7680
• Email: felixsupport[@]fasikl.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• Felix NeuroAI Wristband
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.
• Sham 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).

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou
China	Tianjin Medical University General Hospital	Tianjin
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

Sponsors (1)

Lead Sponsor	Collaborator
Fasikl Inc.

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	14 days, 30 days, and 60 days, 180 days, and 1 year
Secondary	Responder Rate	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.	14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.
Secondary	Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Items 1, 4, and 8	Each TETRAS PS item is scored by physician from 0 to 4, indicating increasing severity of tremor.	Baseline, 30 days, 90 days, and 1 year
Secondary	Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Items 6 and 7	Each TETRAS PS item is scored by physician from 0 to 4, indicating increasing severity of tremor.	Baseline,14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.
Secondary	Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Dominant Hand Score	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.	Baseline, 30 days, 90 days, and 1 year
Secondary	Clinical Global Impression of Severity (CGI-S)	Physician rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)	Baseline, 30 days, 90 days, and 1 year
Secondary	Patient Global Impression of Severity (PGI-S)	Patient rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)	Baseline, 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.
Secondary	Clinical Global Impression of Improvement (CGI-I)	Physician rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)	Baseline, 30 days, 90 days, and 1 year
Secondary	Patient Global Impression of Improvement (PGI-I)	Patient rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)	Baseline, 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.
Secondary	Quality of Life in Essential Tremor Questionnaire (QUEST)	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.	Baseline, 90 days, and 1 year
Secondary	Tremor power	Device measured tremor power. Unit: (m/s^2)^2	Continuously measured up to 1 year
Secondary	Patient survey	Patient survey of satisfaction with the treatment and the durability of the treatment effect	14 days, 30 days, 60 days, 90 days, 180 days, and 1 year