A Study of Wearable Device in Essential Tremor Patients

Not Applicable

• Conditions: Essential Tremor
• Interventions: Device: Apple Watch; Other: BrainRISE app

• Registration Number: NCT05976074
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-07-03
• Study Start: 2023-07-07
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wearable device for tremor assessment	Apple Watch	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.
Wearable device for tremor assessment	BrainRISE app	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 Measures

Name	Time	Method
Acquire high-quality physiological signal characteristics from movement disorder patients.	12 Months	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.
Acquire high-quality physiological tremor signals from movement disorder patients.	12 Months	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.

Secondary Outcome Measures

Name	Time	Method
Subject feedback	12 Months	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.

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States