Back to resultsA Study of Wearable Device in Essential Tremor Patients
Primary Purpose
Essential Tremor
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apple Watch
BrainRISE app
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring Deep Brain Stimulation Therapy
Eligibility Criteria
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: 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.
Sites / Locations
- Mayo Clinic Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wearable device for tremor assessment
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05976074
Brief Title
A Study of Wearable Device in Essential Tremor Patients
Official Title
A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Quantify Tolerance to Deep Brain Stimulation in Essential Tremor Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Deep Brain Stimulation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wearable device for tremor assessment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Apple Watch
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
BrainRISE app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acquire high-quality physiological signal characteristics from movement disorder patients.
Description
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
Title
Acquire high-quality physiological tremor signals from movement disorder patients.
Description
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 Outcome Measure Information:
Title
Subject feedback
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Klassen, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Wearable Device in Essential Tremor Patients
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