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NCT06863207 · ClinicalTrials.gov registry record · NA
Autonomic Reactivity and Personalized Neurostimulation
A NA study of Functional Dyspepsia and Dysautonomia, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06863207 is a NA study of Functional Dyspepsia and Dysautonomia that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 120 participants, above the 60-participant average among 9 other Functional Dyspepsia trials with a reported enrollment target (100% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06863207, a NA study of Functional Dyspepsia and Dysautonomia, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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, autonomi
Conditions Studied
Interventions
- DEVICE Percutaneous electrical nerve field stimulation
- BEHAVIORAL Hypnotherapy
Study Locations (1)
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-01-24 |
| Est. Completion | 2029-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06863207
The ClinicalTrials.gov registry entry for NCT06863207 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 60-participant average among 9 other Functional Dyspepsia trials with a reported enrollment target (100% higher). The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Functional Dyspepsia appearing as the primary indexed condition, and to 2 interventions - of which Percutaneous electrical nerve field stimulation is the first listed.
NCT06863207 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT06863207 about?
NCT06863207 is a clinical study titled "Autonomic Reactivity and Personalized Neurostimulation". 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, dyspepsi...
What is the current status of trial NCT06863207?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2025-01-24. Estimated completion is 2029-06.
What conditions does trial NCT06863207 study?
This clinical trial studies the following conditions: Functional Dyspepsia, Dysautonomia, Cyclic Vomiting Syndrome, Functional Gastrointestinal Disorders (FGIDs).
What interventions are being tested in trial NCT06863207?
The interventions under investigation include: Percutaneous electrical nerve field stimulation (DEVICE), Hypnotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT06863207?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06863207 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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