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 range

12 Years – 18 Years

Sex

FEMALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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