Prospective, multi-center, single-arm, non-significant risk study designed to evaluate the Cala TWO device. Subjects will be screened for eligibility and fitted with a Cala TWO device. Subjects will wear the device at home for a period of 3 months, during which they will be asked to stimulate their dominant hand twice a day. The stimulation amplitude will be based on each subject's stimulation threshold. Subjects will have in clinic assessments at enrollment, month 1 and 3.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
263
Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves
TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score
Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) subset score: TETRAS subset score relevant to the stimulated upper limb. The subset score is the sum of 6 rated tasks. Each task is rated 0 to 4, where a higher score indicates more severe tremor. Minimum subset score = 0; Maximum subset score = 24.
Time frame: Baseline to 3-months
Bain & Findley Activities of Daily Living (ADL) Scale Subset Score
Bain \& Findley ADL subset score relevant to the stimulated upper limb. The subset score is the sum of 8 rated tasks. Each task is rated 1 to 4, where a higher score indicates more severe tremor. Minimum subset score = 8; Maximum subset score = 32.
Time frame: Baseline to 3-months
Kinematic Measurements, as Collected With the Device During Postural Holds, Change From Pre-stimulation to Post-stimulation Across Sessions
Subjects will be prompted to perform a postural hold task before and after each stimulation session. During this task, the device will record kinematic data using on-board motion sensors to objectively assess if there are any changes in tremor level. The change in each patient's pre- and post-stimulation tremor power was defined as the median change over all valid stimulation sessions. Sample mean and standard deviations were computed using the median change value from all patients.
Time frame: Average change in tremor power over 3-month study period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Barrow Neurological Institute (Dignity Health)
Phoenix, Arizona, United States
USC
Los Angeles, California, United States
Parkinson's Institute and Clinical Center
Mountain View, California, United States
University of California San Francisco
San Francisco, California, United States
Pacific Neuroscience Institute
Santa Monica, California, United States
Rocky Mountain Movement Disorders Center
Denver, Colorado, United States
Hospital for Special Care
New Britain, Connecticut, United States
Medstar Gerogetown Health Institute
Georgetown, District of Columbia, United States
Parkinson's Center
Boca Raton, Florida, United States
USF
Tampa, Florida, United States
...and 22 more locations