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Wearable Device for Essential Tremor

N/A
Waitlist Available
Led By Bryan Klassen, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with well-classified essential tremor, who are already receiving regular DBS therapy at Mayo Clinic for their movement disorder.
Be older than 18 years old
Must not have
Presence of open or healing wounds near monitoring sites (infection risk).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial studies how a device can track how Parkinson's symptoms change throughout the day for people using DBS therapy.

Who is the study for?
This trial is for essential tremor patients who are already undergoing DBS therapy at Mayo Clinic. Participants must understand and follow the study procedures, use the BrainRISE app daily, be able to handle a smartphone, and consent to audio/video recording during tasks.Check my eligibility
What is being tested?
The study aims to monitor how well DBS therapy helps with essential tremors throughout the day. Patients will wear an Apple Watch that collects movement data while they perform standardized tasks using the BrainRISE app.See study design
What are the potential side effects?
Since this trial involves monitoring with wearable technology rather than medication or invasive procedures, typical drug-related side effects are not expected. However, discomfort from wearing the device may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have essential tremor and am getting DBS therapy at Mayo Clinic.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have open or healing wounds near where the device would be placed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acquire high-quality physiological signal characteristics from movement disorder patients.
Acquire high-quality physiological tremor signals from movement disorder patients.
Secondary outcome measures
Subject feedback

Trial Design

1Treatment groups
Experimental Treatment
Group I: Wearable device for tremor assessmentExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apple Watch
2022
N/A
~450

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Deep Brain Stimulation (DBS) is a common treatment for Essential Tremor (ET) that involves implanting electrodes in specific brain regions, such as the thalamus, to send electrical impulses that modulate abnormal neural activity. This modulation helps reduce tremor severity by interfering with the pathological neural circuits responsible for the tremors. This mechanism is important for ET patients as it offers significant symptom relief, especially when other treatments are ineffective, thereby enhancing their quality of life.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,356 Total Patients Enrolled
7 Trials studying Essential Tremor
181 Patients Enrolled for Essential Tremor
Bryan Klassen, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
7 Total Patients Enrolled

Media Library

Wearable device for tremor assessment Clinical Trial Eligibility Overview. Trial Name: NCT05976074 — N/A
Essential Tremor Research Study Groups: Wearable device for tremor assessment
Essential Tremor Clinical Trial 2023: Wearable device for tremor assessment Highlights & Side Effects. Trial Name: NCT05976074 — N/A
Wearable device for tremor assessment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05976074 — N/A
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