Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06366074 | NOT YET RECRUITING | Healthy

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

University of Michigan

Information provided by (Responsible Party):

J Ian’s Chen

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.

Condition or disease

Healthy

Intervention/treatment

Watch-TEA group

Tethered TEA device

Phase

NA

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
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device
Actual Study Start Date : 2025-10
Estimated Primary Completion Date : 2026-10
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device

Location Details

NCT06366074

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, road cancer

University of Michigan

Ann Arbor, road cancer, United States, 48109