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

University of Michigan

Status

Withdrawn

Conditions

Healthy

Treatments

Device: Tethered TEA device

Device: Watch-TEA group

Study type

Interventional

Funder types

Other

Identifiers

NCT06366074

HUM00252120

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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