A Study of Wearable Device in Essential Tremor Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Apple Watch, BrainRISE app.
- Who it may be relevant to
- Registry conditions: Essential Tremor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Quantify Tolerance to Deep Brain Stimulation in Essential Tremor Patients
Overview
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.
Interventions
- 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.
Primary outcome measures
- Acquire high-quality physiological signal characteristics from movement disorder patients. [Time frame: 12 Months]
- Acquire high-quality physiological tremor signals from movement disorder patients. [Time frame: 12 Months]
Secondary outcome measures (1)
- Subject feedback [Time frame: 12 Months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic Minnesota — Rochester
Identifiers
NCT: NCT05976074 · 23-004705