A Study of Wearable Device in Essential Tremor Patients
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|ClinicalTrials.gov Identifier: NCT05976074|
Recruitment Status : Enrolling by invitation
First Posted : August 4, 2023
Last Update Posted : August 4, 2023
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Device: Apple Watch Other: BrainRISE app||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Quantify Tolerance to Deep Brain Stimulation in Essential Tremor Patients|
|Actual Study Start Date :||July 7, 2023|
|Estimated Primary Completion Date :||August 2024|
|Estimated Study Completion Date :||August 2024|
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
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.
Other: BrainRISE 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.
- Acquire high-quality physiological signal characteristics from movement disorder patients. [ Time Frame: 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. [ Time Frame: 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.
- Subject feedback [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05976074
|United States, Minnesota|
|Mayo Clinic Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Bryan Klassen, MD||Mayo Clinic|