Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The Effect of T6 Dermatomal Electrical Stimulation on Subjects Stomach Motor Activity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Transcutaneous electrical nerve stimulation (TENS) stimulation
During this TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will take pressure readings after being placed. After four hours, subjects will again be given a second meal. Fifteen minutes of electrical stimulation will be given to subjects fifteen minutes before ingestion of lunch. After ingestion of lunch, 60 minutes of the electrical stimulation will be applied. When the test is done, the tube will be removed.
干预措施: Elira Investigational TENS device (Device)
No TENS stimulation
During this no TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will record stomach pressure readings after being placed. After four hours, subjects will again be given a second meal. The TENS unit stimulation will be placed but no electrical stimulation will be given. When the test is done, the tube will be removed.
干预措施: Elira Investigational TENS device (Device)
结局指标
主要结局
The Effect of T6 Dermatomal Electrical Stimulation on Subjects Stomach Motor Activity
时间窗: through study completion, an average of 1 year
Testing to see if dermatomal electrical stimulation will speed up or slow down the stomach motor activity.
次要结局
未报告次要终点
研究者
Michael Camilleri, MD
Principal Investigator
Mayo Clinic