Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity

Participants will be treated before and after two meals of the day with T6 dermatomal
electrical stimulation delivered by a Transcutaneous Electrical Nerve Stimulation (TENS)
unit. Participants will receive 15-minute T6 dermatome cutaneous stimulation with TENS unit
applied immediately before ingestion of two of main meals of the day (breakfast and evening
meal), and 60 minute stimulation applied immediately after ingestion of these meals.
Participants will apply the stimulus four times daily for a treatment period of at least 3
months. Participants will keep a diary of weight once weekly and a weekly appetite record.

Inclusion Criteria:

- Overweight and obese adults (BMI ≥25 kg/m2 and ≤34.99 kg/m2) residing within 125 miles
of Mayo Clinic in Rochester, Minnesota; these will be otherwise 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.

- Age: 18-65 years

- Gender: Men or women. Women of childbearing potential will be using an effective form
of contraception, and have negative pregnancy tests within 48 hours of enrollment and
before each radiation exposure.

- 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 the duration of the study, unless reviewed and approved by the study team.

Exclusion Criteria:

- 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, appetite or absorption, e.g., Orlistat

- Positive history of diabetes mellitus or use of hypoglycemic medications

- 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) (12), a self-administered alcoholism screening
test (AUDIT-C) (13), and the Questionnaire on Eating and Weight Patterns (binge eating
disorders and bulimia) (14). If such a dysfunction is identified by a HAD score >11 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 including
gastric emptying and gastric accommodation.

- Subjects may also be excluded from participation for other factors at the discretion
of the principal investigator.