Essential Tremor Clinical Trial
Official title:
A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Quantify Tolerance to Deep Brain Stimulation in Essential Tremor Patients
Verified date | August 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Minnesota | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 Months | |
Primary | 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. | 12 Months | |
Secondary | 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. | 12 Months |
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