Effect of T6 Dermatome Electrical Stimulation on Gastrodu... | NCT03316105

NCT03316105

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Elira Therapeutics, Inc.	INDUSTRY

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Elira Investigational TENS device	Device	TENS unit placed on skin will deliver electric stimulation to abdominal area.	No TENS stimulation Transcutaneous electrical nerve stimulation (TENS) stimulation

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Name	Affiliation	Role
Michael Camilleri, M.D	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Arm/Group Information

ID	Title	Description
FG000	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. Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area.
FG001	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. Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Electrical device malfunction; recruitment was stopped.

Posted

through study completion, an average of 1 year

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms