Personalized neurostimulation for children with gastrointestinal disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of personalized percutaneous electrical nerve field stimulation (PENFS) combined with hypnotherapy to treat children suffering from functional gastrointestinal disorders (FGIDs) and autonomic nervous system dysregulation. The researchers aim to assess real-time autonomic nervous system (ANS) regulation using a novel software while personalizing stimulation parameters based on individual sensory thresholds. The study will evaluate the feasibility and efficacy of these interventions over a six-week period, focusing on improvements in symptoms and autonomic function. By understanding the underlying mechanisms of gut-brain interaction, the study seeks to provide targeted treatment options for affected children.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 11 to 18 years of age
* English speaking
* meeting Rome IV diagnostic criteria for cyclic vomiting syndrome or functional dyspepsia and willingness to participate and consent/assent to the study
* All subjects will have a constellation of chronic symptoms indicative of autonomic dysfunction for minimum 3 months: postural dizziness/lightheadedness, syncope, palpitations, fatigue, sleep disturbance, thermoregulatory abnormalities and cognitive impairment with upright position +/- abnormal autonomic testing if performed per standard of care as per American Autonomic Society consensus criteria.

Exclusion Criteria:

* Presence of organic disease that may explain symptoms
* Requirement for parenteral nutrition
* Developmental delays precluding accurate symptom report
* Severe dermatological condition or active infection of external or middle ear
* Implanted electrical device
* Severe mental health disorder not controlled by therapy (schizophrenia, bipolar disease, severe depression, post-traumatic distress disorder) and/or psychotic features which could influence symptom report or ANS measurements and result in adverse reactions to hypnosis therapy

Where it's running

• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Katja Karrento, MD — Medical College of Wisconsin
• Study coordinator: Elaina Schueler, BS
• Email: eschueler@mcw.edu
• Phone: 4142663695

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.