Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  1. Healthy volunteers with BMI ≤34.99 kg/m^2 residing within 125 miles of Mayo Clinic in Rochester, MN; 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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Michael Camilleri, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20341685

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