Clinical trial NCT03316105: Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers
Official title: Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Weight Loss
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Elira Therapeutics, Inc.
First posted: 2017-10-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 activity.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of the test day.
3. Subjects must have the ability to provide informed consent before any trial-related activities.
4. 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 Criteria:

1. Abdominal surgery other than appendectomy, Caesarian section or tubal ligation.
2. Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility.
3. Positive history of spinal cord injury and/or chronic back pain.
4. 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.
5. 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.
6. Subjects may also be excluded from participation for other factors at the discretion of the principal investigator.

Primary outcomes:
measure: The Effect of T6 Dermatomal Electrical Stimulation on Subjects Stomach Motor Activity
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, M.D
role: PRINCIPAL_INVESTIGATOR
References: