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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06366074
• Other study ID #: HUM00252120
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Colin Burnett
• Phone: 734-647-2806
• Email: bucolin[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Transtimulation Research, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)