Patient Enrollment and Training
tremor, comorbidity
Patients in both arms scheduled an appointment with patient support personnel at Cala Health to complete enrollment and training on proper use of the device (Cala Trio™, Cala Health, San Mateo, CA, USA). All patients received a standard TAPS delivery containing three components sent directly to their home: (1) a wrist-worn stimulator that delivers an individualized stimulation pattern to the median and radial nerves, and measures patients’ tremor during postural holds with an on-board accelerometer, (2) a detachable wristband with multiple embedded electrodes configured to target the median and radial nerves, and (3) a cloud-connected base station which charges the stimulator and securely transmits all device data to a cloud platform (All patients in the TX arm completed standard TAPS training with the Cala Trio device. The training included instructions to perform postural holds before and after stimulation sessions for measuring tremor power, self-administer 40-minute stimulation sessions as needed to control their tremor, report complaints, and a reminder to continue with any other ET-related care and comorbidity management recommended by their physician. Patients in the TX arm were instructed to use the device as-needed according to the instructions for use, which states that “Cala Trio therapy should be applied when temporary relief of hand tremor is desired (i.e., before activities involving your hands such as meals or writing).” Patients in the SOC arm were given instructions to measure tremor power once a day with the Cala Trio device, without delivering stimulation, for one month. Additional study-specific training was given to both arms and included instruction on completing a Bain & Findley Activities of Daily Living (BF-ADL) upper limb rating assessment scale at baseline and one month, and notifying study personnel of any therapy modifications, as applicable. The wording used on the BF-ADL survey for the upper limb tasks and ratings matched that from the original publication [