NCT05540626

RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor

Real World Evidence Study Utilizing the Cala Trio Device in Patients With Essential Tremor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Cala Health, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	Cala Trio	transcutaneous afferent patterned stimulation (TAPS)

Timeline

• Start date: 2021-04-08
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-09-14
• Last updated: 2025-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study