A Study of Wearable Device in Essential Tremor Patients

• ClinicalTrials.gov Identifier: NCT05976074
• Recruitment Status: Enrolling by invitation
• First Posted: August 4, 2023
• Last Update Posted: August 4, 2023
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Bryan T. Klassen, M.D., Mayo Clinic

Tracking Information

• First Submitted Date: July 3, 2023
• First Posted Date: August 4, 2023
• Last Update Posted Date: August 4, 2023
• Actual Study Start Date: July 7, 2023
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2023)

• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 3, 2023)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Essential Tremor

Intervention

• 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.

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.

Interventions:

• Device: Apple Watch
• Other: BrainRISE app

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: August 3, 2023): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2024
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05976074
• Other Study ID Numbers: 23-004705
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Bryan T. Klassen, M.D., Mayo Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bryan Klassen, MD; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: August 2023