20 Participants Needed

TEA Device Usability and Safety Study

CB
Overseen ByColin Burnett
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the TEA Device treatment?

Research shows that transcutaneous electrical nerve stimulation (TENS), a similar type of electrical stimulation, is effective in relieving both acute and chronic pain. This suggests that the TEA Device, which uses electrical stimulation, may also be effective for pain relief.12345

Is the TEA Device safe for humans?

Research on similar devices, like the tibial nerve stimulation device, shows they are generally safe for home use, focusing on safety and acceptability.26789

How is the TEA Device treatment different from other treatments for this condition?

The TEA Device treatment is unique because it uses transcutaneous electrical acustimulation, which is a non-invasive method that stimulates nerves through the skin to potentially improve symptoms. This approach is different from other treatments that may involve medication or more invasive procedures.510111213

What is the purpose of this trial?

This project is being completed to test the usability and safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device.This is a pilot study that will lead to future projects for cancer patients that may experience chemotherapy-induced symptoms.

Research Team

JC

Jiande Chen, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Watch-TEAExperimental Treatment2 Interventions
Group II: Tethered TEA deviceExperimental Treatment2 Interventions

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
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]
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.
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]

References

Electrical Stimulation in Clinical Practice. [2019]
Tolerability of facial electrostimulation in healthy adults and patients with facial synkinesis. [2021]
Comparison of the efficacy of transcutaneous electrical nerve stimulation, interferential currents, and shortwave diathermy in knee osteoarthritis: a double-blind, randomized, controlled, multicenter study. [2013]
Influence of Therapeutic Approach in the TENS-induced Hypoalgesia. [2017]
Dose-specific effects of transcutaneous electrical nerve stimulation (TENS) on experimental pain: a systematic review. [2022]
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. [2023]
Effects of antecedent TENS on EMG activity of the finger flexor muscles and on grip force. [2009]
Feasibility of using a novel non-invasive ambulatory tibial nerve stimulation device for the home-based treatment of overactive bladder symptoms. [2022]
Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia. [2016]
10.United Statespubmed.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. [2018]
Low TENS treatment on post-stroke paretic arm: a three-year follow-up. [2017]
Effect of transcutaneous electrical nerve stimulation induced parotid stimulation on salivary flow. [2021]
Immediate effects of transcutaneous electrical stimulation on physiological swallowing effort in older versus young adults. [2018]
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