A prospective, open-label, multi-center pilot study designed to evaluate the safety and effectiveness of the Felix system in the relief of upper limb tremors in adults with essential tremor and Parkinson's disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Felix is a wrist-worn, noninvasive, transcutaneous neurostimulation system intended for daily use to suppress hand tremors. An artificial intelligence (AI) algorithm will automatically adjust the stimulation based on each patient's tremor throughout the day.
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Performance Subscale
A subset of 6 performance tasks will be rated by a physician for each upper limb separately. Each task will be rated from 0 to 4, indicating the increasing severity of tremor, the higher the score, the worse the tremor. This endpoint is the total score of all 6 tasks, the minimum score is 0 and the maximum score is 24.
Time frame: Baseline to 7 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 to 7 days
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Activities of Daily Living (ADL) Subscale
Patient rating the impact of tremor on each activity of daily living on a 5-point scale, from 0 (normal) to 4 (severely abnormal). This is a composite endpoint that includes the total score of all 12 items of the TETRAS ADL subscale. The minimum score is 0 and the maximum score is 48.
Time frame: Baseline to 7 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 to 7 days
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Modified Activities of Daily Living (mADL) Subscale
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 on the TETRAS ADL subsacle and the TETRAS PS subscale is rated from 0 (no tremor) to 4 (severe tremor). TETRAS mADL score is calculated as the sum of all 13 items, the minimum score is 0 and the maximum score is 52.
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Time frame: Baselinen to 7 days