Trial Outcomes & Findings for Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers (NCT NCT03316105)

Results Overview

Testing to see if dermatomal electrical stimulation will speed up or slow down the stomach motor activity.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

through study completion, an average of 1 year

Results posted on

2019-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	9	7
Overall Study COMPLETED	9	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TENS Unit Stimulation n=9 Participants 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.	No TENS Unit Stimulation n=7 Participants 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.	Total n=16 Participants Total of all reporting groups
Age, Continuous	40.1 years STANDARD_DEVIATION 11.6 • n=9 Participants	34 years STANDARD_DEVIATION 7.9 • n=7 Participants	36.6 years STANDARD_DEVIATION 10.0 • n=16 Participants
Sex: Female, Male Female	5 Participants n=9 Participants	3 Participants n=7 Participants	8 Participants n=16 Participants
Sex: Female, Male Male	4 Participants n=9 Participants	4 Participants n=7 Participants	8 Participants n=16 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	7 participants n=7 Participants	16 participants n=16 Participants

PRIMARY outcome

Timeframe: through study completion, an average of 1 year

Population: Electrical device malfunction; recruitment was stopped.

Testing to see if dermatomal electrical stimulation will speed up or slow down the stomach motor activity.

Outcome measures

Outcome data not reported

Adverse Events

TENS Unit Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No TENS Unit Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Camilleri, M.D.

Mayo Clinic

Phone: 507-284-2687

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place