Autonomic Reactivity and Personalized Neurostimulation

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06863207
Status
Recruiting
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Conditions

  • Cyclic Vomiting Syndrome
  • Dysautonomia
  • Functional Dyspepsia
  • Functional Gastrointestinal Disorders (FGIDs)

Eligibility Criteria

Sex
FEMALE
Age
11 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Percutaneous electrical nerve field stimulation — DEVICE
    Percutaneously nerve stimulator applied to the external auricle weekly for several consecutive weeks of therapy
  • Hypnotherapy — BEHAVIORAL
    Gut-directed hypnotherapy delivered via audio recordings

Study Details

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.

Key Dates

Start date
Jan 24, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PENFS (percutaneous electrical nerve field stimulation) therapy
    Personalized PENFS therapy x 6 weeks based on weekly autonomic nervous system assessments
  • Active Comparator: PENFS (percutaneous electrical nerve field stimulation) therapy + Hypnotherapy
    Personalized PENFS therapy x 6 weeks based on weekly autonomic nervous system assessments + adjuntive hypnotherapy

Primary Outcome Measure

Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile-37 [ Time Frame: From enrollment to end of treatment at 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53005
Lisa Nielson, BS
[email protected]
414-266-3695
[email protected]
Katja Karrento, MD (PRINCIPAL_INVESTIGATOR)

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