Personalized neurostimulation for children with gastrointestinal disorders
Autonomic Reactivity to Restore a Dysregulated Brain-Gut Axis Via Targeted Therapy
This study is testing a new treatment that combines personalized nerve stimulation and hypnotherapy to see if it can help children with stomach problems feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 11 Years to 18 Years |
| Sex | Female |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06863207 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English-speaking children aged 11 to 18 who meet diagnostic criteria for cyclic vomiting syndrome or functional dyspepsia and exhibit symptoms of autonomic dysfunction.
Not a fit: Patients with organic diseases explaining their symptoms, severe mental health disorders, or those requiring parenteral nutrition are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective, personalized treatments for children with debilitating gastrointestinal disorders and associated autonomic dysfunction.
How similar studies have performed: While the approach of combining neurostimulation with hypnotherapy is innovative, similar studies have shown promise in treating related conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milwaukee, Wisconsin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.