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

NCT03316105 | Terminated Results FDA Device

• 1 other identifier: 17-004101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Transcutaneous electrical nerve stimulation (TENS) stimulation

ACTIVE COMPARATOR

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.

Device: Elira Investigational TENS device

No TENS stimulation

SHAM COMPARATOR

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.

Device: Elira Investigational TENS device

Interventions

Elira Investigational TENS device DEVICE

TENS unit placed on skin will deliver electric stimulation to abdominal area.

Also known as: Electric Stimulation from TENS unit

No TENS stimulation; Transcutaneous electrical nerve stimulation (TENS) stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Elira Therapeutics, Inc.: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael Camilleri, M.D.
• Organization: Mayo Clinic

camilleri.michael@mayo.edu

507-284-2687

Study Officials

• Michael Camilleri, M.D

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 20, 2017
• Study Start: September 6, 2017
• Primary Completion: June 21, 2018
• Study Completion: June 21, 2018
• Last Updated: May 30, 2019
• Results First Posted: May 30, 2019

Record last verified: 2019-05

Locations

US (1)