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

NCT06366074 | Withdrawn FDA Device

• 1 other identifier: HUM00252120
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Usability; Early feasibility; Safety

Outcome Measures

Primary Outcomes (5)

• 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: 1. \- Mild averse event (AE) - No treatment needed 2. \- Moderate AE - Resolved with treatment 3. \- Severe AE - Inability to carry on normal activities, required professional medical attention 4. \- Life-threatening or disabling AE 5. \- 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: 1. \- Mild AE - No treatment needed 2. \- Moderate AE - Resolved with treatment 3. \- Severe AE - Inability to carry on normal activities, required professional medical attention 4. \- Life-threatening or disabling AE 5. \- Fatal AE

  Daily for 3 days

• Number of non-treatment TEA adverse events for both groups

  Adverse events will be noted by the following: 1. \- Mild AE - No treatment needed 2. \- Moderate AE - Resolved with treatment 3. \- Severe AE - Inability to carry on normal activities, required professional medical attention 4. \- Life-threatening or disabling AE 5. \- Fatal AE

  up to 1-2 weeks (after baseline visit 1)

Study Arms (2)

Watch-TEA

EXPERIMENTAL

Device: Watch-TEA group; Device: Tethered TEA device

Tethered TEA device

EXPERIMENTAL

Device: Watch-TEA group; Device: Tethered TEA device

Interventions

Watch-TEA group 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.

Tethered TEA device; Watch-TEA

Tethered TEA device 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.

Tethered TEA device; Watch-TEA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Transtimulation Research, Inc: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Jiande Chen, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Model Details: Prevalence of delayed Chemotherapy-induced nausea, emesis, and dyspeptic symptoms (CINEDS) is 75% in women vs 51% in men (60% to 40% ratio). Therefore, every effort will be made to recruit at least 60% female subjects into the clinical study.

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 15, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months of completing the study

Locations

US (1)