CClinicalTrials.gg
Enrolling by invitationNCT05976074Updated Oct 29, 2025

A Study of Wearable Device in Essential Tremor Patients

An interventional study of Apple Watch and BrainRISE app in Essential Tremor, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-29.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Essential Tremor

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Keywords

  • Deep Brain Stimulation Therapy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with well-classified essential tremor, who are already receiving regular DBS therapy at Mayo Clinic for their movement disorder.
  • Ability to understand study procedures and to comply with them for the entire length of the study and use study devices as outlined in protocol.
  • Patient agrees to perform daily tasks in BrainRISE app and consents to the study collecting video and audio recordings during those tasks.
  • Proficient in the use of a smart phone.

Exclusion criteria

Exclusion Criteria:

  • Cognitive or psychiatric condition rendering a patient unable to cooperate with data collection, or to manage and recharge smart watch and tablet computer devices.
  • Presence of open or healing wounds near monitoring sites (infection risk).
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study 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.

    Device: Apple Watch · Other: BrainRISE app

Interventions

  • DeviceApple 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.

  • OtherBrainRISE 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.

05

What researchers measure

Primary outcomes

  1. Acquire high-quality physiological signal characteristics from movement disorder patients.

    Acquisition of high-quality physiological signals from 50 subjects with movement disorders over the course of two weeks and up to thirty subjects over one day with 90% compliance rate as determined by the number of study tasks completed by participants.

    Time frame: 12 Months

  2. Acquire high-quality physiological tremor signals from movement disorder patients.

    Measured by wrist accelerometry, which tracks the acceleration of the patients' wrists and is reported in m/sec\^2 on a scale where 1.0 = 9.8m/s\^2.

    Time frame: 12 Months

Secondary outcomes

  1. Subject feedback

    Subject comfort, compliance, and convenience during the data collection as determined by a post-study assessment asking patients to rate their experience on a scale of 1-5 from hardest and most inconvenient to easiest and least inconvenient.

    Time frame: 12 Months

06

Study locations

1 site
  • Mayo Clinic Minnesota
    Rochester, Minnesota 55905, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05976074
Lead sponsor
Mayo Clinic
Responsible party
Bryan T. Klassen, M.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Aug 4, 2023
Start date
Jul 7, 2023
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Oct 29, 2025

Study contacts

Bryan Klassen, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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