HealthyNCT06366074
Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device
A study testing Watch-TEA group and Tethered TEA device in people with Healthy, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Watch-TEA group and Tethered TEA device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Watch-TEA group, Tethered TEA device
- Keywords
- Usability, Early feasibility, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watch-TEA groupDevice
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 deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Watch-TEA | Experimental | Not described Receives: Device: Watch-TEA group; Device: Tethered TEA device |
| Tethered TEA device | Experimental | Not described Receives: Device: Watch-TEA group; Device: Tethered TEA device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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:
- - 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
Measured: 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:
- - 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
Measured: Daily for 3 days
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
Measured: up to 1-2 weeks (after baseline visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Why it stopped: The study was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Transtimulation Research, Inc
- Responsible party
- Principal investigator, Jiande Chen, University of Michigan
- Investigators
- Jiande Chen, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366074
- Sponsor's protocol ID
- HUM00252120
- Status last verified
- Sep 2025
- First submitted
- 1 Apr 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study team plans to share that information within 3 months of completing the study.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device
- ClinicalTrials.gov ID
- NCT06366074
- Acronym / sponsor ID
- HUM00252120
- Conditions
- Healthy
- Keywords
- Usability, Early feasibility, Safety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Transtimulation Research, Inc
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Watch-TEA | Experimental | Device: Watch-TEA group, Device: Tethered TEA device |
| Tethered TEA device | Experimental | Device: Watch-TEA group, Device: Tethered TEA device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watch-TEA groupSubjects 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. | Device | Tethered TEA device, Watch-TEA |
| Tethered TEA deviceSubjects 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. | Device | Tethered TEA device, Watch-TEA |
Primary outcome
Usability of the device for both groups day 3
Time frame: 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.
Number of adverse events related to the device noted on the safety questionnaire
Time frame: 1-2 weeks (after baseline visit 1)
A safety questionnaire with 3 questions about skin irritation, pain, or infection. Visit 2 is at 1-2 weeks after visit 1.
Number of Transcutaneous Electrical Acustimulation (TEA)-related adverse events for both groups 3 days
Time frame: Day 3
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
Number of TEA-related adverse events for both groups 60 minutes at maximal tolerable level
Time frame: Daily for 3 days
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
Number of non-treatment TEA adverse events for both groups
Time frame: up to 1-2 weeks (after baseline visit 1)
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: Yes. The study team plans to share that information within 3 months of completing the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiande Chen, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watch-TEA group and Tethered TEA device in people with Healthy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the device for both groups day 3 (time frame: Day 3). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.