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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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 belowSelect...
I have essential tremor and am getting DBS therapy at Mayo Clinic.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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
2015
N/A
~440
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,438 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can follow the study's procedures and use its devices as required.I have open or healing wounds near where the device would be placed.I have essential tremor and am getting DBS therapy at Mayo Clinic.I agree to use the BrainRISE app daily and allow it to record me.You have a condition that makes it hard for you to understand or use the smart watch and tablet computer devices for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Wearable device for tremor assessment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for recruitment into this clinical trial currently?
"At this time, the clinical trial posted on July 7th 2023 is not enrolling patients. However, there are 58 other trials actively seeking participants as listed on the same website."
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