Status:
TERMINATED
Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Elira Therapeutics, Inc.
Conditions:
Weight Loss
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators are doing this research study to find out the effect of T6 Dermatomal Electrical Stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit) on stomach motor...
Eligibility Criteria
Inclusion
- Healthy volunteers with BMI ≤34.99 kg/m\^2 residing within 125 miles of Mayo Clinic in Rochester, Minnesota; these will be healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia on diet) disorders.
- Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of the test day.
- Subjects must have the ability to provide informed consent before any trial-related activities.
- Eligible individuals will be asked to avoid taking additional medications and supplements for one week before and after the test day, unless reviewed and approved by the study team.
Exclusion
- Abdominal surgery other than appendectomy, Caesarian section or tubal ligation.
- Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility.
- Positive history of spinal cord injury and/or chronic back pain.
- Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD). If such a dysfunction is identified by a HAD score \>11 on either Anxiety or Depression or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
- Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, thyroxine replacement therapy, low dose analgesia or anti-inflammatory medications (Acetaminophen and Ibuprofen) and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility.
- Subjects may also be excluded from participation for other factors at the discretion of the principal investigator.
Key Trial Info
Start Date :
September 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03316105
Start Date
September 6 2017
End Date
June 21 2018
Last Update
May 30 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905