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

N/A

Waitlist Available

Led By Gisela Chelimsky, MD

Research Sponsored by Gisela Grotewold Chelimsky

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, week 4, and week 8. score changes from baseline to week 4 and baseline to week 8 are reported.

Summary

This trial will test if a device that sends electrical signals can help kids with stomach issues by stimulating the vagus nerve.

Eligible Conditions

Irritable Bowel Syndrome
Indigestion
Dysautonomia
Nausea
Functional Gastrointestinal Disorders

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, week 4, and week 8. score changes from baseline to week 4 and baseline to week 8 are reported.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, week 4, and week 8. score changes from baseline to week 4 and baseline to week 8 are reported.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, week 4, and week 8. score changes from baseline to week 4 and baseline to week 8 are reported. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Change in Heart Rate Variability at 4 Weeks

+3 more

Secondary study objectives

Change From Baseline in Functional Disability Inventory (Child and Adolescent)

Change From Baseline in Functional Disability Inventory (Parent)

Change From Baseline in Pain Catastrophizing Scale (Child)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Stimulation (8)Experimental Treatment1 Intervention

Participants will receive active auricular microstimulation via TENS unit for 8 weeks. Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.

Group II: Sham Stimulation (4), Active (4)Placebo Group2 Interventions

Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks. Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous Electrical Nerve Stimulation (TENS)

2023

N/A

~960

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