Status:
TERMINATED
Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Functional Gastrointestinal Disorders
Eligibility:
FEMALE
12-21 years
Phase:
NA
Brief Summary
This study is to determine if the auricular microstimulator produces the expected increase in HRV.
Detailed Description
The aim of this proposal is to determine if utilizing an affordable tool like microstimulation utilizing a transcutaneous electric nerve stimulator (TENS) unit and applying the stimulation to the ear ...
Eligibility Criteria
Inclusion
- Female
- 12 - 21 years old
- Either diagnosed OR not diagnosed with chronic idiopathic nausea, functional abdominal pain, dyspepsia and/or irritable bowel syndrome.
- English speaking
Exclusion
- Patients who are unable to stand upright during the heart rate variability recording
- Patients with a known bleeding disorder
- Patients with swollen, infected, inflamed, or other skin eruptions on outer ear
- Patients with epilepsy
- Patients with any implanted cardiac pacemaker or defibrillator
- Patients with serious arterial circulatory problems in the lower limbs
- Patients with abdominal or inguinal hernia
- Patients who are pregnant
- Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc.
- Requires new medication during the 4 weeks of the study that may affect the gastrointestinal symptoms, vagal modulation or immune response.
- Practices over 1 hour of aerobic activity a day
- Daily practice of abdominal breathing (yoga)
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05987813
Start Date
October 18 2023
End Date
June 4 2024
Last Update
December 27 2024
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23219