Weight Loss
Conditions
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.
Interventions
DEVICEElira Investigational TENS device
TENS unit placed on skin will deliver electric stimulation to abdominal area.
Sponsors
Elira Therapeutics, Inc.
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of T6 Dermatomal Electrical Stimulation on Subjects Stomach Motor Activity | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TENS Unit 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.
Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area. | 9 |
| No TENS Unit 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.
Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area. | 7 |
| Total | 16 |
Baseline characteristics
| Characteristic | No TENS Unit Stimulation | Total | TENS Unit Stimulation |
|---|---|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 7.9 | 36.6 years STANDARD_DEVIATION 10 | 40.1 years STANDARD_DEVIATION 11.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 7 participants | 16 participants | 9 participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 7 |
| other Total, other adverse events | 0 / 9 | 0 / 7 |
| serious Total, serious adverse events | 0 / 9 | 0 / 7 |
Outcome results
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.
Time frame: through study completion, an average of 1 year
Population: Electrical device malfunction; recruitment was stopped.