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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03316105
• Other study ID #: 17-004101
• Status: Terminated
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: June 21, 2018

Study information

• Verified date: May 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: June 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Weight Loss

Intervention

Device:
• Elira Investigational TENS device
TENS unit placed on skin will deliver electric stimulation to abdominal area.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Elira Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effect of T6 Dermatomal Electrical Stimulation on Subjects Stomach Motor Activity	Testing to see if dermatomal electrical stimulation will speed up or slow down the stomach motor activity.	through study completion, an average of 1 year