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Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device

NCT06366074 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-09-12

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DEVICE

Watch-TEA group

Subjects will wear the device for 3 days. The subjects will self-apply the TEA for 60 min once daily with the current amplitude set at a maximal tolerable level. To increase the subject compliance, two measures will be implemented: timely alerts by the app (and phone calls, if needed) for performing the TEA sessions, and recording full history of therapy sessions on the device for monitoring the compliance.

DEVICE

Tethered TEA device

Subjects will wear the device for 3 days. The subjects will self-apply the TEA for 60 min once daily with the current amplitude set at a maximal tolerable level. To increase the subject compliance, two measures will be implemented: timely alerts by the app (and phone calls, if needed) for performing the TEA sessions, and recording full history of therapy sessions on the device for monitoring the compliance.

Sponsors & Collaborators

Principal Investigators

  • Jiande Chen, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06366074 on ClinicalTrials.gov