Not provided
Not provided
Not provided
Not provided
Not provided
The study was not funded.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Transtimulation Research, Inc | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Watch-TEA | Experimental |
| |
| Tethered TEA device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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:
| 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:
| Daily for 3 days |
| Number of non-treatment TEA adverse events for both groups |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jiande Chen, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
The study team plans to share that information within 3 months of completing the study.
3 months of completing the study
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
Adverse events will be noted by the following:
| up to 1-2 weeks (after baseline visit 1) |