Autonomic Reactivity and Personalized Neurostimulation

Launched by MEDICAL COLLEGE OF WISCONSIN · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Autonomic Reactivity and Personalized Neurostimulation," is studying how certain disorders that affect the gut and brain work together, especially in children aged 8 to 18 who have conditions like cyclic vomiting syndrome or functional dyspepsia. These conditions can cause symptoms such as nausea, vomiting, dizziness, and fatigue, and might be linked to problems with the autonomic nervous system (ANS), which controls many automatic body functions. The researchers aim to use a new method to track how the ANS responds in real time and provide personalized treatment through a technique called auricular percutaneous electrical nerve field stimulation (PENFS). This method is designed to help improve patients' symptoms by focusing on the specific needs of each child.

To participate in the trial, children must be aged 8 to 18, speak English, and meet specific diagnostic criteria for their condition. They should also have experienced chronic symptoms related to ANS dysfunction for at least three months. However, children with certain serious health issues or mental health disorders that could impact their ability to participate will not be eligible. Participants can expect to engage in a study that aims to improve understanding and treatment of their symptoms, and potentially benefit from tailored therapies that have shown promise in previous research.

Gender

FEMALE

Eligibility 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