What side effects are associated with this type of intervention?

Deep Brain Stimulation (DBS) for Essential Tremor can cause side effects such as infection, hemorrhage, confusion, and seizures, although severe adverse effects are uncommon. Hardware malfunctions are more frequent but generally correctable, and stimulation-related complications are usually reversible by adjusting the stimulation settings. Noninvasive neuromodulation therapies, like transcranial magnetic stimulation (TMS), may cause mild side effects such as lightheadedness, tingling, and tinnitus, with the most serious being a generalized tonic-clonic seizure, though this is rare.

What prior FDA approvals exist?

Deep Brain Stimulation (DBS) is an FDA-approved treatment for Essential Tremor, particularly for patients who do not respond to medication. DBS involves implanting a device that sends electrical impulses to specific brain areas to modulate neural activity and reduce tremor severity. Other treatments for Essential Tremor include medications like propranolol and primidone, but these are pharmacological rather than neuromodulation therapies.

What other types of research exist?

Promising novel alternatives to Deep Brain Stimulation for Essential Tremor patients include: 1) Wearable devices that collect movement and physiological data to monitor and potentially modulate tremor symptoms. 2) Transcranial direct current stimulation (tDCS), which has shown potential in improving naming accuracy and is being evaluated for other neurological conditions. 3) MRI-guided focused ultrasound thalamotomy, which creates a lesion in the ventral intermediate (VIM) nucleus of the thalamus to treat tremor without the need for invasive surgery.

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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 involves patients with DBS therapy wearing an Apple Watch to track their movements and body functions. The goal is to understand how the benefits of DBS change over time.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acquire high-quality physiological signal characteristics from movement disorder patients.

Acquire high-quality physiological tremor signals from movement disorder patients.

Secondary study objectives

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

~550

0 / 2Eligibility criteria met

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.