Clinical trial NCT06235190: Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Essential Tremor
Lead sponsor: Fasikl Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 90 days
Secondary outcomes:
measure: 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
timeFrame: 14 days, 30 days, and 60 days, 180 days, and 1 year
measure: Responder Rate
timeFrame: 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.
measure: Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Items 1, 4, and 8
timeFrame: Baseline, 30 days, 90 days, and 1 year
measure: Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Items 6 and 7
timeFrame: Baseline,14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.
measure: Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Dominant Hand Score
timeFrame: Baseline, 30 days, 90 days, and 1 year
measure: Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline, 30 days, 90 days, and 1 year
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: Baseline, 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.
measure: Clinical Global Impression of Improvement (CGI-I)
timeFrame: Baseline, 30 days, 90 days, and 1 year
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: Baseline, 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.
measure: Quality of Life in Essential Tremor Questionnaire (QUEST)
timeFrame: Baseline, 90 days, and 1 year
measure: Tremor power
timeFrame: Continuously measured up to 1 year
measure: Patient survey
timeFrame: 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Palo Alto
country: United States
facility: Parkinson's Research Centers of America - Palo Alto
state: California
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Kansas City
country: United States
facility: The University Of Kansas Medical Center
state: Kansas
city: Commack
country: United States
facility: Parkinson's Research Centers of America - Long Island
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
References: