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Autonomic Reactivity and Personalized Neurostimulation

RecruitingNAAges 11 Years - 18 YearsFemaleMedical College of Wisconsin
NCT06863207 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Disorders of gut-brain interaction (DGBI) affect up to 25% of U.S. children. Patients often suffer from disabling, multisystem comorbidities that suggest a common root (sleep disturbances, fatigue, anxiety, etc). Yet, DGBI are defined and treated based on GI symptom origin (cyclic vomiting, dyspepsia, irritable bowel) rather than underlying pathophysiology. Many patients manifest comorbidities suggesting an underlying autonomic nervous system (ANS) dysregulation (palpitations, dizziness, cognitive dysfunction). Unfortunately, due to common features of anxiety and visceral hyperreactivity and lack of obvious pathology, children with DGBI are frequently diagnosed with psychosomatic or 'benign, functional disorders' and treated with empiric antidepressants despite lack of scientific support and risks of serious side effects. Little is known about the underlying brain-gut mechanisms linking

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📋 Eligibility rules (as published)
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
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What it tests

  • Percutaneous electrical nerve field stimulation
  • Hypnotherapy
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Where

1 site
Medical College of Wisconsin
Milwaukee, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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