Wearable Device for Essential Tremor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Cognitive, Psychiatric, Wounds, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of deep brain stimulation (DBS) for individuals with essential tremor, a condition causing uncontrollable shaking. Participants will use an Apple Watch, a wearable device, to track movements and other body data during specific daily tasks. This trial suits those who have received DBS therapy at Mayo Clinic for their essential tremor and are comfortable using a smartphone. As an unphased trial, it offers a unique opportunity to contribute to cutting-edge research and enhance future treatments for essential tremor.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves patients already receiving DBS therapy, it seems likely that you can continue your current treatment.

What prior data suggests that this wearable device is safe for tremor assessment?

Research has shown that wearable devices, like smartwatches, are generally safe and easy to use for checking tremors. Studies have found that these devices can accurately track tremor activity without causing harm. For instance, research using smartwatch sensors successfully detected tremors in both patients and healthy individuals. Participants in these studies did not report any major side effects from using the devices.

Moreover, wearable technology has been used safely in other movement disorders, indicating a strong safety record. These devices are designed to monitor rather than alter bodily functions, which helps reduce risks. Overall, using a smartwatch to track tremors is considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the wearable device for essential tremor because it offers a new, non-invasive way to monitor tremors in real-time. Unlike traditional treatments that focus on medication or surgical interventions like deep brain stimulation, this approach uses an Apple Watch to track tremor activity. This innovative method allows for continuous assessment through the BrainRISE app, potentially providing more personalized insights into tremor patterns and treatment effectiveness. By offering a flexible and easy-to-use option, this wearable technology could enhance how patients and doctors manage essential tremor.

What evidence suggests that this wearable device is effective for essential tremor?

Research has shown that wearable devices like smartwatches can help monitor essential tremor. One study used a smartwatch with sensors to track tremor severity in patients for over 11 hours a day, offering useful insights into tremor patterns. Another study found that the Felix NeuroAI wristband significantly reduced tremor symptoms compared to a placebo device. These findings suggest that wearable technology can aid in tracking and possibly improving tremor management in daily life. In this trial, participants will use a wearable device for tremor assessment, which could be a valuable tool for people with essential tremor. ^{6 7 8 9 10}

Who Is on the Research Team?

Bryan Klassen, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can follow the study's procedures and use its devices as required.

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.

Exclusion Criteria

I have open or healing wounds near where the device would be placed.

Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

You have a condition that makes it hard for you to understand or use the smart watch and tablet computer devices for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects already implanted with a DBS system wear an Apple Watch and complete tremor assessment tasks four times a day for two weeks

2 weeks

Daily tasks (4 times a day)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Wearable Device

Trial Overview 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.

How Is the Trial Designed?

Group I: Wearable device for tremor assessment Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Assistive devices, such as limb weights and handheld devices, can effectively reduce tremor severity and improve functional performance in patients, offering a safe and low-cost adjunct to current treatments for tremor disorders.

Despite their potential benefits, the adoption of assistive technologies is hindered by concerns about privacy, trust, and functionality, highlighting the need for interdisciplinary evaluation to enhance accessibility and user comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving functional disability in patients with tremor: A clinical perspective of the efficacies, considerations, and challenges of assistive technology. Bhidayasiri, R., Maytharakcheep, S., Phumphid, S., et al.[2022]

A significant portion of medical device adverse event reports submitted to the FDA's MAUDE database (approximately 47.9%) were classified as categories other than death, despite containing terms indicating that a patient had died.

The study found that about 23% of reports involving patient deaths were misclassified, suggesting that around 31,552 reports may have inaccurately categorized deaths, highlighting a critical need for improved accuracy in adverse event reporting to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death. Lalani, C., Kunwar, EM., Kinard, M., et al.[2022]

There is a significant gap in the safety evaluation of non-active implantable medical devices (NAIMDs) compared to medicines, particularly in the absence of a global program for collecting and analyzing adverse events and product quality issues.

Adopting methodologies from drug safety evaluations, such as utilizing real-world data sources like electronic health records and implementing unique device identifiers (UDI), could enhance the ongoing monitoring and assessment of NAIMD safety throughout their entire life cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. Pane, J., Coloma, PM., Verhamme, KM., et al.[2018]

A new classification monitoring model for adverse events related to medical devices was developed, which helps in systematically assessing and managing risks associated with these devices.

This model aims to enhance the reporting and quality of adverse events, allowing regulatory bodies to focus their supervision efforts more effectively, ultimately improving device safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research on Classification Monitoring Model of Medical Device Adverse Events Based on Risk Management]. Ren, W., Zhu, Q., Ding, J., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5350115/

Continuous Monitoring of Essential Tremor Using a ... A new highly portable system was used to monitor tremor continuously during daily lives. It consists of a smartwatch with a triaxial accelerometer, a smartphone ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405844025020961

Assessment of overall essential tremor severity by ... Twelve ET patients were monitored with an inertial sensor embedded in a smartwatch for an average of 11.61 ± 1.99 h per day over 6.67 ± 2.19 days.

3. nature.com nature.com/articles/s41531-024-00721-2

Using a smartwatch and smartphone to assess early ... As measured by the smartwatch, the average (SD) arm swing in-clinic decreased from 25.9 (15.3) degrees at baseline to 19.9 degrees (13.7) at ...

4. neurologylive.com neurologylive.com/view/felix-neuroai-wristband-demonstrates-superiority-over-sham-device-tranquil-study-essential-tremor

Felix NeuroAI Wristband Demonstrates Superiority Over ... The Felix NeuroAI wristband significantly reduced essential tremor symptoms, outperforming a sham device in the TRANQUIL study. Participants ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05976074/a-study-of-wearable-device-in-essential-tremor-patients?phase=6&study_type=Interventional&id=1007&slug=dystonia

A Study of Wearable Device in Essential Tremor Patients The purpose of this research is to observe the daily loss of benefit from DBS therapy by performing a standardized set of tasks throughout ...

6. nature.com nature.com/articles/s41598-025-08244-3

Smartwatch-based wrist tremor assessment in ... Wrist tremor assessment using a smartwatch confirmed the positive impact of video-based and augmented reality training on neurosurgical residents' confidence.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7928701/

Digital Technology in Movement Disorders Wearable devices, mainly wrist-worn sensors, have also been used in essential tremor (ET). Smartwatches are able to quantify tremor, have shown ...

8. mdpi.com mdpi.com/1424-8220/25/14/4313

Smart Watch Sensors for Tremor Assessment in ... This study aimed to develop and validate a tremor-detection algorithm using smartwatch sensors. Data were collected from 21 individuals with PD and 27 healthy ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1388245725002901

A prospective controlled study of a wearable rhythmic ... This study is one of the first controlled large sample studies to investigate how ViS may influence the objective measures of tremor in PD.

10. withpower.com withpower.com/trial/phase-tremor-6-2023-5be54

Wearable Device for Essential Tremor · Info for Participants 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 ...