The study objective is to evaluate hand tremor relief in the treated hand following stimulation with the Cala Trio Device in adults with essential tremor, and healthcare resource utilization and total healthcare costs over a 12-month period.
This is a prospective, randomized, dual arm, pragmatic trial in a real-world setting to evaluate the effectiveness and health economics outcomes of the Cala Trio device in reducing hand tremor and improving quality of life as measured by the Bain and Findley Activities of Daily Living (ADL) score relevant to the stimulated upper limb. Healthcare resources utilization and total all-cause healthcare will also be evaluated. The study will recruit approximately 300 patients: 150 in the intervention arm (Cala Trio device)and 150 patients in the standard of care (SOC) arm. Subjects will be randomized to either the intervention arm or the standard of care arm (1:1).Subjects in the SOC arm will be asked to measure their tremor severity by doing daily postural holds with the Cala Trio device without actual stimulation. Subjects in the intervention arm will wear the device at home for a period of 12 months, during which they will deliver 40 min stimulation sessions, which can be started and stopped on demand. After the first month, the subjects who were randomized to the SOC arm will cross over to the intervention arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
transcutaneous afferent patterned stimulation (TAPS)
Cala Health
San Mateo, California, United States
Change in tremor power
Difference in tremor power after stimulation with Cala Trio (treated arm) and baseline tremor power without stimulation (SOC arm) over the first month of the study. Prior to and immediately after each of the first 40 stimulation sessions and every 7th session thereafter, the Cala Trio will direct the patient to perform postural hold tremor tasks to measure tremor power pre and post stimulation. The SOC arm will perform a tremor measurement only, without any stimulation sessions, for 1 month.
Time frame: 1 Month
Bain & Findley Activities of Daily Living (BF-ADL) scale subset score
BF-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. Improvements in BF-ADL scores will be measured from baseline over the 12 months study duration.
Time frame: 12 Months
Tremor power improvement ratio (TPIR)
TPIR is defined as the ratio of pre- to post-stimulation tremor power. Per-patient median TPIR over first, second, third, and fourth quarters of the study (i.e., months 1 - 3, 4 - 6, etc.) will be assessed.
Time frame: 12 Months
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