An interventional study of Percutaneous electrical nerve field stimulation and Hypnotherapy in Functional Gastrointestinal Disorders (FGIDs), Cyclic Vomiting Syndrome and Functional Dyspepsia, sponsored by Medical College of Wisconsin. Recruiting at 1 site in United States. Open to female participants aged 11 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
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.
The investigators hypothesize that children with cyclic vomiting syndrome (CVS) and chronic nausea/vomiting with concurrent symptoms of autonomic nervous system (ANS) dysregulation have reduced vagal efficiency (VE) that can be captured by the ANS Tracker software and modulated via adjustable percutaneous electrical nerve field stimulation (PENFS). Our overall goals are to: 1) expand knowledge on mechanisms of disorders of gut brain interaction involving VE and gastric function, 2) test a software that allows point of care VE assessment, 3) personalize PENFS parameters with real-time assessments of VE and gastric function, 4) combine and assess efficacy of two proven, effective therapies for DGBI that both modulate CNS.
The specific aims of this study are as follows:
Aim 1: Test the feasibility of real-time autonomic nervous system (ANS) tracking in children with nausea/vomiting and ANS dysregulation The investigators will test feasibility of assessing real-time ANS regulation by the VE metric using a novel ANS tracker software in response to posture shifts during PENFS with 1) standard and 2) personalized stimulation parameters based on sensory thresholds in female children with nausea/vomiting.
Aim 2: Compare efficacy and ANS changes with personalized PENFS +/- adjunctive hypnotherapy The investigators will assess outcomes of 6 weeks of personalized PENFS based on sensory threshold (Aim 1) vs. personalized PENFS with adjunctive hypnotherapy via weekly assessments of VE and symptom response. Baseline VE measurements will be correlated with outcomes to assess ability to predict treatment response.
Aim 3: Investigate dynamic gastric function in response to personalized PENFS The investigators will test real-time gastric function pre and post therapy (Aim 2 interventions) by advanced MRI in a subset of female patients vs. healthy controls.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
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Exclusion Criteria:
Personalized PENFS therapy x 6 weeks based on weekly autonomic nervous system assessments
Device: Percutaneous electrical nerve field stimulation
Personalized PENFS therapy x 6 weeks based on weekly autonomic nervous system assessments + adjuntive hypnotherapy
Device: Percutaneous electrical nerve field stimulation · Behavioral: Hypnotherapy
Percutaneously nerve stimulator applied to the external auricle weekly for several consecutive weeks of therapy
Gut-directed hypnotherapy delivered via audio recordings
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile-37
Validated quality of life instrument assessing physical, emotional, and psychosocial functioning in children across 6 domains (subscales). Scores range from 0 (minimum) to 5 (maximum). A lower score indicates improved quality of life for the Anxiety, Depression, Fatigue and Pain Interference domains/subscales. A higher scores indicates improvement in the Physical Function and Peer Relationships subscales. Scores are converted to a T-score where a score of 50 represents the mean.
Time frame: From enrollment to end of treatment at 6 weeks
2. Patient Assessment of upper GastroIntestinal Symptom Severity Index
Upper gastrointestinal symptoms including symptoms of gastroparesis will be assessed via this 20-item instrument with scores ranging from 0 (minimum) to 5 (maximum). Higher scores indicate worse outcome.
Time frame: From enrollment to the end of treatment at 6 weeks.
Plan to share: Yes — The investigators plan to share anonymized, IPD including primary outcome data (PAGI-SYM results) through the publicly accessible Vivli Center for Global Clinical Research Data repository, an NIH supported repository and global data-sharing platform that promotes sharing of individual, participant-level clinical data from clinical trials.
Supporting information: Study protocol
Time frame: Scientific data will be made available no later than the time of an associated publication or the end of the performance period (June 2029), whichever comes first. The investigators anticipate that data will be available for approximately 7-10 years, provided that software upgrades during that time allow compatibility.
Access criteria: Any researcher can access de-identified IPD including study protocol, manual of operations, any data collection forms and results of primary outcome via Vivli Center for Global Clinical Research Data Repository.
Data sharing details ↗ · vivli.org
Started Jan 2025 (actual). Primary completion is estimated for Dec 2028, 47 months after the start.
Of 127 non-industry interventional studies with no phase under Gastrointestinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 47 months is above that.
Counting every sponsor, half of 149 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
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