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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
126
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.
The sham device has the same exterior appearance and components as the Felix device and is used the same way (without delivering the treatment).
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
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.
Time frame: 90 days
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.
Time frame: 14 days, 30 days, and 60 days, 180 days, and 1 year
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.
Time frame: 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
Each TETRAS PS item is scored by physician from 0 to 4, indicating increasing severity of tremor.
Time frame: Baseline, 30 days, 90 days, and 1 year
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.
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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
...and 2 more locations
Time frame: 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
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.
Time frame: Baseline, 30 days, 90 days, and 1 year
Clinical Global Impression of Severity (CGI-S)
Physician rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
Time frame: Baseline, 30 days, 90 days, and 1 year
Patient Global Impression of Severity (PGI-S)
Patient rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
Time frame: Baseline, 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.
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)
Time frame: Baseline, 30 days, 90 days, and 1 year
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)
Time frame: Baseline, 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.
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.
Time frame: Baseline, 90 days, and 1 year
Tremor power
Device measured tremor power. Unit: (m/s\^2)\^2
Time frame: Continuously measured up to 1 year
Patient survey
Patient survey of satisfaction with the treatment and the durability of the treatment effect
Time frame: 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year