A Study of Wearable Device in Essential Tremor Patients

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05976074
Status
Enrolling By Invitation

Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apple Watch — DEVICE
    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.
  • BrainRISE app — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jul 7, 2023
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Wearable device for tremor assessment
    Subjects already implanted with a deep brain stimulation (DBS) system for therapy for essential tremor wear an Apple Watch and complete tremor assessment tasks detailed through the BrainRISE app four times a day for two weeks.

Primary Outcome Measure

Acquire high-quality physiological signal characteristics from movement disorder patients. [ Time Frame: 12 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic MinnesotaRochesterMinnesota55905-

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By research site
Mayo Clinic Minnesota· Rochester, MN

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