ClinicalTrials.gg
Enrolling by invitationNCT05976074Updated Oct 2, 2026

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 2026-10-02.

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

Updated Oct 2, 2026Primary completion movedStudy completion movedGo to Updates ↓
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

In context

Essential Tremor

272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.

This study's planned enrollment of 50 is above the median of 25 across 189 interventional studies indexed under Essential Tremor.

Browse Essential Tremor studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.

06

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Aug 2028, 61 months after the start.

Of 77 non-industry interventional studies with no phase under Essential Tremor, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 26. This study's planned 61 months is above that.

Counting every sponsor, half of 95 studies reached it within 45 months; a quarter within 19 and three quarters within 93.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 2, 2026: primary completion Aug 2026 → Aug 2028 and completion Aug 2026 → Dec 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 3, 2023
First posted
Aug 4, 2023
StartActual
Jul 7, 2023
Primary completionEst.
Aug 2028was Aug 2026
CompletionEst.
Dec 2028was Aug 2026
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 2026→Aug 2028
Oct 2, 2026
Study completion
Aug 2026→Dec 2028
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Primary completion Aug 2026→Aug 2028
    Study completion Aug 2026→Dec 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

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 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 2, 2026

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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No contact was published for this record. The registry link below has the sponsor’s details.

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