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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the wearable device treatment for essential tremor?

Research shows that a wearable orthosis with a motor and algorithm can reduce tremor energy significantly, from 55.49 to 15.66 in active mode, indicating its potential effectiveness in managing essential tremor. ^{1 2 3 4 5}

Is the wearable device for essential tremor safe for humans?

The safety of medical devices, including wearable devices, is monitored through reports of adverse events (unexpected problems) submitted to databases like the FDA's MAUDE. These reports help identify potential safety issues, but there is no global program that comprehensively collects and analyzes all adverse events for medical devices. Efforts are being made to improve the monitoring and evaluation of device safety. ^{6 7 8 9 10}

How does the wearable device treatment for essential tremor differ from other treatments?

The wearable device for essential tremor is unique because it uses a non-invasive orthosis (a supportive device) with a motor and gyroscope to detect and suppress tremors in real-time, unlike traditional treatments like medication or deep brain stimulation. This device offers a new approach by mechanically altering the movement of the upper limb to reduce tremor severity, providing an alternative for those who may not respond well to conventional therapies. ^{1 4 11 12 13}

What is the purpose of this trial?

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.

Research Team

Bryan Klassen, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of a wearable orthosis and an associated algorithm for tremor suppression. [2007]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Essential tremor quantification based on the combined use of a smartphone and a smartwatch: The NetMD study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Wearable Peripheral Electrical Stimulation Devices for the Reduction of Essential Tremor: A Review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Wearable sensors during drawing tasks to measure the severity of essential tremor. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Therapeutic advances in tremor. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Medical device active surveillance of spontaneous reports: A literature review of signal detection methods. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. [2018]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Challenges Associated with the Safety Signal Detection Process for Medical Devices. [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Research on Classification Monitoring Model of Medical Device Adverse Events Based on Risk Management]. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Preliminary Assessment of the Safety of a Fault-Tolerant Control-based Wearable Tremor Suppression Glove. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Mechanical suppression of essential tremor. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Improving functional disability in patients with tremor: A clinical perspective of the efficacies, considerations, and challenges of assistive technology. [2022]