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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03316105
Other study ID # 17-004101
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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