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

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Device: Watch-TEA group; Device: Tethered TEA device

Detailed Description

This project will include three different aims (aim three is a clinical trial) and will be funded by the National Institute of Health (NIH). In aims 1 and 2 the device hardware and device application will be developed and will not be included in this registration as these are not clinical trials. However, aim three is being registered early in the project in order to obtain the Notice of Award (NOA) funding from the NIH. Once the NOA has been obtained the registration will be updated.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants that are willing and able to come to the clinic for two scheduled visits
• Participants are capable of understanding clinical study procedures
• Participants agree to complete the questionnaires

Exclusion Criteria:

• Participants with implanted medical devices for electrical stimulation (e.g. cardiac pacemaker)
• Those enrolled in a concurrent clinical study
• Those 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Watch-TEA	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.
Experimental: Tethered TEA device	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the device for both groups day 3	Questionnaires are administered online and there are 17 usability questions in the questionnaire. All answers use 0-to-5 scale (0 - no,1 - minor, 2 - some, 3 - considerable, 4 - major, 5 - critical) with a range of 0-85 with a higher score meaning more usable.	Day 3
Number of adverse events related to the device noted on the safety questionnaire	A safety questionnaire with 3 questions about skin irritation, pain, or infection. Visit 2 is at 1-2 weeks after visit 1.	1-2 weeks (after baseline visit 1)
Number of Transcutaneous Electrical Acustimulation (TEA)-related adverse events for both groups 3 days	These will include skin irritation, pain, or infection under the Watch-TEA and tethered TEA devices after wearing each device for 3 consecutive days. Adverse events will be noted by the following: - Mild averse event (AE) - No treatment needed; - Moderate AE - Resolved with treatment; - Severe AE - Inability to carry on normal activities, required professional medical attention; - Life-threatening or disabling AE; - Fatal AE	Day 3
Number of TEA-related adverse events for both groups 60 minutes at maximal tolerable level	The subjects will self-apply the TEA for 60 minutes once daily with the current amplitude set at a maximal tolerable level. Events collected will include skin irritation, pain, or infection. Adverse events will be noted by the following: - Mild AE - No treatment needed; - Moderate AE - Resolved with treatment; - Severe AE - Inability to carry on normal activities, required professional medical attention; - Life-threatening or disabling AE; - Fatal AE	Daily for 3 days
Number of non-treatment TEA adverse events for both groups	Adverse events will be noted by the following: - Mild AE - No treatment needed; - Moderate AE - Resolved with treatment; - Severe AE - Inability to carry on normal activities, required professional medical attention; - Life-threatening or disabling AE; - Fatal AE	up to 1-2 weeks (after baseline visit 1)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Transtimulation Research, Inc
• Investigators: Principal Investigator: Jiande Chen, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Usability; Early feasibility
• Other Study ID Numbers: HUM00252120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study team plans to share that information within 3 months of completing the study.
• IPD Sharing Time Frame: 3 months of completing the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No