NCT05976074

A Study of Wearable Device in Essential Tremor Patients

A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Quantify Tolerance to Deep Brain Stimulation in Essential Tremor Patients

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to observe the daily loss of benefit from DBS therapy by performing a standardized set of tasks throughout the day while wearing an Apple Watch to collect movement and other physiological data.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	Apple Watch	The smartwatch will collect data including accelerometry, heart rate, activity, move time, exercise time, stand time, steps, walking and running distance, heart rate variability, respiratory rate, six-minute walk, and flights climbed. During sleep, the smartwatch will collect daily nighttime physiologic data such as time in bed, average sleep time, sleep efficiency, wake after sleep onset, nocturnal heart rate, and nocturnal respiratory rate.
OTHER	BrainRISE app	The app will play a prerecorded video, which will walk participants through tasks which include holding your arms in different postures, repeating different vowel sounds and phrases as prompted, and tracing different patterns on the phone screen. The tasks are video and audio recorded while being completed. Completing the tremor assessment tasks will take about 10 minutes.

Timeline

• Start date: 2023-07-07
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2023-08-04
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study