TEA Device Usability and Safety Study

Overseen By Colin Burnett

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Implanted devices, Concurrent study, Compliance issues, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the ease and safety of using the TEA device, a wearable gadget designed to alleviate symptoms caused by chemotherapy. The study evaluates two versions of the TEA device: a watch-like version and a tethered version connected by a wire. The goal is to gather information that could aid future studies focused on helping cancer patients. Participants should be able to visit the clinic twice and complete some questionnaires. Individuals with implanted medical devices like pacemakers or those participating in another study are not eligible to join. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cancer care.

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

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team to get a clear answer.

What prior data suggests that the Watch-Transcutaneous Electrical Acustimulation (TEA) Device is safe?

Research shows that the Watch-Transcutaneous Electrical Acustimulation (TEA) Device is generally easy to use. Other studies have found that similar devices help with issues like knee pain and reflux, with no major safety problems reported.

For the Tethered TEA device, some studies suggest it might cause minor side effects, such as low blood pressure or a mild fever, but these are rare. The device sends a gentle electrical current through the skin, similar to acupuncture but without needles.

Overall, both devices have been used safely in other studies, indicating they are well-tolerated by most people. However, the long-term effects of this type of electrical stimulation remain unclear. Discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Watch-Transcutaneous Electrical Acustimulation (TEA) Device because it offers a non-invasive way to manage conditions typically treated with medications or other invasive procedures. Unlike traditional treatments, which may involve drug therapies with potential side effects, the Watch-TEA device uses electrical stimulation on the skin to potentially alleviate symptoms. This method not only avoids the complications associated with medication but also provides a portable and user-friendly alternative. Additionally, the Tethered TEA device offers a similar approach but with a different form factor, potentially catering to varied patient needs and preferences.

What evidence suggests that the TEA device is effective for usability and safety?

Research has shown that Transcutaneous Electrical Acustimulation (TEA) devices, such as the Watch-TEA, can help reduce pain. In this trial, participants will use either the Watch-TEA or the tethered TEA device. Previous studies have found that TEA can improve knee pain and works well alongside exercise therapy. Specifically, research suggests that the tethered TEA device safely reduces pain in various conditions. This method uses a gentle electrical current on specific body points to ease discomfort. These findings suggest that TEA devices could effectively manage pain-related symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

Jiande Chen, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for healthy individuals who are interested in participating in a study to evaluate the usability and safety of a new device called Watch-TEA. Specific eligibility criteria have not been provided, but typically participants should meet certain health standards.

Inclusion Criteria

I understand the procedures involved in the clinical study.

I can visit the clinic twice as scheduled.

Participants agree to complete the questionnaires

Exclusion Criteria

Participants with implanted medical devices for electrical stimulation (e.g. cardiac pacemaker)

Participants enrolled in a concurrent clinical study

Participants unable to comply with the study protocol due to a disease, psychiatric illness, alcoholism, substance abuse, geographic distance, or other factors that would place the study participant at increased risk or preclude the study participant's full compliance with or completion of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants self-apply the TEA device for 60 minutes once daily at a maximal tolerable level

3 days

Daily self-application

Follow-up

Participants are monitored for adverse events related to the device

1-2 weeks

1 visit (in-person) at 1-2 weeks after baseline

What Are the Treatments Tested in This Trial?

Interventions

• Watch-Transcutaneous Electrical Acustimulation (TEA) Device

Trial Overview The focus of this early-feasibility study is on the Watch-Transcutaneous Electrical Acustimulation (TEA) Device. Participants will use this tethered TEA device to assess how user-friendly and safe it is, paving the way for its potential future use by cancer patients.

How Is the Trial Designed?

Group I: Watch-TEA Experimental Treatment 2 Interventions

Group II: Tethered TEA device Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Transtimulation Research, Inc

Collaborator

Trials

3

Recruited

70+

Published Research Related to This Trial

The study found that the wearable integrated volitional control electrical stimulation (WIVES) device is as effective as the conventional integrated volitional control electrical stimulation (IVES) device in improving upper extremity function in patients with paresis after stroke, with both groups showing significant improvements in the Fugl-Meyer Assessment of the upper extremity.

WIVES treatment demonstrated a mean improvement of 6.0 in the Fugl-Meyer Assessment, indicating that this more portable device can effectively support rehabilitation in daily life without compromising efficacy compared to the traditional device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Integrated Volitional Control Electrical Stimulation Device as Treatment for Paresis of the Upper Extremity in Early Subacute Stroke Patients: A Randomized Controlled Non-inferiority Trial. Maeda, H., Hishikawa, N., Sawada, K., et al.[2023]

In a study involving 203 patients with knee osteoarthritis, all treatment groups (TENS, IFCs, SWD) showed significant improvements in pain and function, but there were no major differences in effectiveness among the active treatments compared to sham interventions.

Patients receiving active treatments had a significantly lower intake of paracetamol compared to those in sham groups, indicating that physical therapy modalities may enhance pain relief beyond exercise and education alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of transcutaneous electrical nerve stimulation, interferential currents, and shortwave diathermy in knee osteoarthritis: a double-blind, randomized, controlled, multicenter study. Atamaz, FC., Durmaz, B., Baydar, M., et al.[2013]

Limited output transcranial electrical stimulation (tES) devices, such as tDCS, tACS, and tPCS, have been shown to have electrical output levels significantly lower than many FDA-cleared devices, suggesting they pose minimal risk when responsibly manufactured and marketed.

The paper establishes a comprehensive framework for the regulation and manufacturing standards of low-power tES devices, promoting safety and innovation while ensuring public access to these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk. Bikson, M., Paneri, B., Mourdoukoutas, A., et al.[2018]

In a three-year follow-up study of 28 stroke patients, low-frequency transcutaneous electrical nerve stimulation (low TENS) did not lead to long-term improvements in arm motor function, as both treatment and control groups experienced deterioration in motor function over time.

However, the low TENS group maintained their activities of daily living (ADL) scores, while the control group showed a decline, suggesting that low TENS may help preserve daily functioning despite not improving motor recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low TENS treatment on post-stroke paretic arm: a three-year follow-up. Sonde, L., Kalimo, H., Fernaeus, SE., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10199978/

Efficacy and Safety of Transcutaneous Electrical Acupoint ... TEAS may be a potential alternative for parturients as a simple, noninvasive, and non-pharmacological intervention compared with EA in terms of analgesic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06721572

Role of Home-Based Transcutaneous Electrical ... TEA transmits a weak electrical current using electrodes placed at acupoints and has shown to safely reduce pain in other gastrointestinal conditions. This ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/P240031B.pdf

summary of safety and effectiveness data (ssed) The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of sacral electrical stimulation with the Neuspera SNM ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12118493/

Effects of Transcutaneous Electrical Acustimulation on ... Previous studies have shown that TEA is effective in treating pain-related conditions. This study aims to evaluate the efficacy and mechanisms of TEA treatment ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05519683

Home Transcutaneous Electrical Acustimulation (TEA) The aim of this study is to investigate the potential of TEA to treat abdominal pain in participants with IBS with constipation (IBS-C).

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/k030375.pdf

1. Trade Name - accessdata.fda.gov Warnings: The long-term effects of prolonged use of cutaneous electrodes for electrical stimulation are unknown. Electrodes should not be applied over the ...

7. fcc.report fcc.report/FCC-ID/2ATA8-SNM-FDC01/4375053.pdf

SNM-FDC01 Transcutaneous Electrical Acustimulator (TEA ... None of TEA Device stimulation programs are designed for injured or disease afflicted skin. Its use on such skin is contraindicated. TEA Device electrical ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9023215/

Efficacy and Safety of Transcutaneous Electrical Acupoint ... This meta-analysis aims to evaluate the effectiveness and safety of transcutaneous electrical acupoint stimulation (TEAS) in treating post-operative pain.