Autonomic Reactivity and Personalized Neurostimulation for Functional GI Disorders

This study is for young women aged 11 to 18 who have certain functional gastrointestinal disorders (FGIDs) like cyclic vomiting syndrome or functional dyspepsia, along with symptoms of autonomic dysfunction (problems with body functions like heart rate or digestion). Researchers are testing two treatments: percutaneous electrical nerve field stimulation (PENFS), which involves a small device placed on the ear, and gut-directed hypnotherapy using audio recordings. The main goal is to see how these treatments affect your overall well-being, measured by a survey called PROMIS Pediatric Profile-37, from when you join until the end of treatment at 6 weeks. This study aims to understand how these treatments can help with symptoms that often come with FGIDs, such as dizziness, lightheadedness, and palpitations.

Study design: This is an interventional study with a planned enrollment of 120 participants. It is not specified if the study is randomized or blinded.
What's involved: You would receive percutaneous electrical nerve field stimulation (PENFS) applied to your ear weekly for several consecutive weeks. You would also use gut-directed hypnotherapy delivered via audio recordings.
Compensation: Not stated in the trial record.
Follow-up: Your well-being will be measured from enrollment until the end of treatment at 6 weeks.

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Autonomic Reactivity and Personalized Neurostimulation

Recruiting

NAAges 11–18InterventionalTreatment

Medical College of Wisconsin

~120 participants

Updated 2026-02-13 on ClinicalTrials.gov

What's tested:Percutaneous electrical nerve field stimulationHypnotherapy

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile-37

Measured over From enrollment to end of treatment at 6 weeks

Conditions

Functional Gastrointestinal Disorders (FGIDs)

Cyclic Vomiting Syndrome

Functional Dyspepsia

Dysautonomia

Where it's being run

1 sites across 1 states

Wisconsin1

Study leadership

Katja Karrento, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Elaina Schueler, BS

[email protected]

4142663695

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Eligibility criteria

Inclusion

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

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

What this trial measures

Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile-37From enrollment to end of treatment at 6 weeks
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.

Trialytics