RecruitingNot ApplicableNCT06863207

Autonomic Reactivity and Personalized Neurostimulation

Autonomic Reactivity to Restore a Dysregulated Brain-Gut Axis Via Targeted Therapy


Sponsor

Medical College of Wisconsin

Enrollment

120 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 these comorbidities. A lack of targeted treatment options naturally follows the paucity of mechanistic data. A dysregulated ANS response circuit via brainstem nuclei is linked to visceral hypersensitivity. As the team's prior research has shown, ANS regulation can be non-invasively measured via several validated indices of cardiac vagal tone. Using the novel vagal efficiency (VE) metric, the investigators have demonstrated inefficient vagal regulation in cyclic vomiting syndrome and pain-related DGBI and that low VE predicts response to non-invasive, auricular percutaneous electrical nerve field stimulation (PENFS) therapy. PENFS targets brainstem vagal afferent pathways and, along with brain-gut interventions such as hypnotherapy, are the only therapies currently proven effective for pediatric DGBI. Individualizing neurostimulation based on sensory thresholds while assessing dynamic ANS reactivity offers a path towards personalized medicine using the most effective therapies to date. This proposal will test the feasibility of an ANS tracking software in assessing real-time, autonomic regulation and providing individualized neurostimulation in children with nausea/vomiting and ANS imbalance.


Eligibility

Sex: FEMALEMin Age: 11 YearsMax Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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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Interventions

DEVICEPercutaneous electrical nerve field stimulation

Percutaneously nerve stimulator applied to the external auricle weekly for several consecutive weeks of therapy

BEHAVIORALHypnotherapy

Gut-directed hypnotherapy delivered via audio recordings


Locations(1)

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT06863207


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