TerminatedNot Applicable

A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders

Stopped: Funding ended prior to hitting the enrollment goal

United States10 participantsStarted 2020-09-01

Plain-language summary

The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by stimulation of the vagus nerve. The study will compare two methods of stimulation to determine if there is a difference in the two methods.

Who can participate

Age range12 Years – 18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female patients 12-18 years old with chronic idiopathic nausea, function abdominal pain, dyspepsia and/or irritable bowel syndrome * English Speaking Exclusion Criteria: * Patients who are unable to stand upright during the heart rate variability recording * Patients with a known bleeding disorder * Gastric or cardiac pacer or defibrillator * Poor circulation in lower limbs * Swollen or inflamed outer ear * Epilepsy * Abdominal or inguinal hernia * Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc. * Requires new medication during the 8 weeks of the study that may affect gastrointestinal symptoms, vagal modulation or immune response * Inability to answer questionnaires or report pain on a 0-10 visual analog scale.

What they're measuring

Change in Heart Rate Variability at 4 Weeks

Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.

Change in Heart Rate Variability at 8 Weeks

Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.

Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 4 Weeks (Basal Consumption)

Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.

Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 8 Weeks (Basal Consumption)

Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.

Change in Blood Cytokines Measured by TNF α Levels at 4 Weeks

Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.

Change in Blood Cytokines Measured by TNF α Levels at 8 Weeks

Timeframe: Assessed at baseline, week 4, and week 8. Change in baseline to week 8.

Trial details

NCT IDNCT04247100

SponsorGisela Grotewold Chelimsky

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-23

Results submitted2023-03-10

View on ClinicalTrials.gov More Functional Gastrointestinal Disorders trials