Personalized Neurostimulation to Improve Autonomic Nervous System Function in Girls Ages 11 to 18 with Cyclic Vomiting and Functional Gastrointestinal Disorders

What this Trial Is About

This research aims to better understand disorders of gut-brain interaction DGBI in female children aged 11 to 18 who experience symptoms like cyclic vomiting and functional dyspepsia along with signs of autonomic nervous system ANS imbalance. These conditions often include disabling symptoms such as sleep disturbances, fatigue, anxiety, palpitations, and dizziness. The study focuses on the brain-gut mechanisms behind these symptoms and evaluates treatments targeting the ANS regulation through novel methods. Participants will receive personalized percutaneous electrical nerve field stimulation PENFS therapy applied to the external ear for six weeks. Some will also receive adjunctive gut-directed hypnotherapy through audio recordings. The study evaluates real-time ANS regulation using a new tracking software and adjusts neurostimulation parameters based on individual sensory thresholds. A subset of participants will undergo advanced MRI to assess gastric function before and after therapy. Throughout the study, participants will be monitored weekly for autonomic nervous system activity and symptom changes using patient-reported outcomes and gastrointestinal symptom severity assessments. Researchers will measure vagal efficiency and symptom response to personalize treatment. The trial includes a six-week treatment period with follow-up evaluations to assess therapy effects. Safety and symptom reporting will be carefully observed during the study period.

Autonomic Reactivity and Personalized Neurostimulation