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Active Stimulation (8) for Indigestion

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.
Awards & highlights

Study 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
  • Indigestion
  • Nausea
  • Functional Gastrointestinal Disorders
  • Vagus Nerve Dysfunction
  • Irritable Bowel Syndrome

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.
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
~720

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Who is running the clinical trial?

Gisela Grotewold ChelimskyLead Sponsor
Chelimsky, Gisela GrotewoldLead Sponsor
Gisela Chelimsky, MDPrincipal InvestigatorVirginia Commonwealth University
2 Previous Clinical Trials
108 Total Patients Enrolled
~2 spots leftby Jun 2025
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