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
125
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 13 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
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 13 items and ranges from 0 to 52.
Time frame: 14 days, 30 days, and 60 days
Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Dominant Hand Score
The sum of TETRAS PS items 4 (3 sub-items), 6, 7, and 8 for the dominant hand. Each item is scored by physician from 0 to 4, indicating increasing severity of tremor. TETRAS PS score is calculated as the sum of all 6 items and ranges from 0 to 24. Items 4 and 8 can only assess in-clinic, because clinical follow-up at 14 days and 60 days are conducted remotely, this outcome measure is not available for those timepoints.
Time frame: Baseline, 30 days, and 90 days
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, and 90 days
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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
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, and 90 days
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, and 90 days
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, and 90 days
Quality of Life in Essential Tremor Questionnaire (QUEST)
QUEST Total activity and psychosocial score is a 27-item scale that covers Work and Finances, Hobbies and Leisure, Physical, and Psychosocial aspects of QOL. Each item is rated based on how frequent does tremor interfere with this activity, the answers are Never/No (0), Rarely (1), Sometimes (2), Frequently (3) Always/Yes (4). The final total score was calculated: the sum of individual scores / total possible points (i.e., 27x4) times 100.
Time frame: Baseline and 90 days