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
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Time frame: Baseline to 7 days
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Physician rated MDS-UPDRS Part III on a 5-point scale, from 0 (normal) to 4 (severe)
Time frame: Baseline to 7 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 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 on a 5-point scale, from 0 (normal) to 4 (severely abnormal)
Time frame: Baseline to 7 days
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 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tremor Power
Assessed by device sensor.
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). TETRAS mADL score is calculated as the sum of all 12 items and ranges from 0 to 52.
Time frame: Baselinen to 7 days