Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05212129
Status
Recruiting
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Conditions

  • Autonomic Nervous System Disease
  • Autonomic Nervous System Imbalance
  • Functional Gastrointestinal Disorders
  • Hypermobile Ehlers-Danlos Syndrome
  • Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Percutaneous vagal nerve stimulation (pVNS) device — DEVICE
    Subjects in Treatment Arm B will enter a six-week, prospective open label treatment trial with the FDA-approved and commercially available device IB-Stim. This is an ambulatory, neurostimulation device which consists of a battery powered, externally affixed generator with 4 wire leads attached to electrode/needle arrays affixed to the outer ear. The device delivers low voltage (3.2V) stimulation in alternating frequencies for a total of 5 days (around the clock).
  • Acoustic vagal nerve stimulation (aVNS) treatment — OTHER
    All subjects receiving acoustic therapy via active VNS (aVNS; n=30) or sham VNS (sVNS; n=30) will enter a four-week, randomized, double-blind clinical trial during which they will listen to either computer altered/filtered vocal music (active treatment) that has been designed to stimulate vagal calming vs. regular non-filtered music (sham treatment). The stimuli will mirror the acoustic intervention known as the Safe and Sound Protocol. This protocol has been found to reduce auditory hypersensitivities and calming the autonomic nervous system by increasing vagal regulation of the heart via brainstem ventral vagal complex. The acoustic intervention may be played by an electronic device (i.e. smartphone, tablet, laptop, mp3) and delivered virtually with the help of trained coaches.

Study Details

Hypermobile Ehlers-Danlos Syndrome (hEDS) is a connective tissue disorder characterized by hyperextensible skin, joint hypermobility and additional connective tissue manifestations. For unclear reasons, hEDS is associated with many gastrointestinal (GI) and autonomic nervous system (ANS) complaints such as postural orthostatic tachycardia syndrome (POTS). This study will address the clinical relationship between hEDS/Hypermobile Spectrum Disorders and autonomic regulation and see if there is a benefit of two forms of non-invasive vagal nerve stimulation therapies to reduce GI symptoms in hEDS and POTS. The study will also investigate plausible effects of these nerve stimulation therapies on gastric function and autonomic signaling.

Key Dates

Start date
Apr 5, 2021
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Active Comparator: Treatment Arm A (hEDS)
    (n=60) patients who meet criteria for hEDS or Hypermobile Spectrum Disorder (HSD) will receive aVNS (acoustic vagal nerve stimulation) therapy via filtered vocal music sound therapy using the Safe and Sound protocol (randomized 1:1 to active vs sham music; double blind study design)
  • Experimental: Treatment Arm B (ANS Dysfunction)
    (n=30) patients with concerns for ANS dysfunction (with or without hEDS) will receive auricular percutaneous vagal nerve stimulation (pVNS) therapy. Additional sub-study option: 15-20 subjects will undergo gastric MRI and (those who consent to it) will also participate in a biobank blood sample collection study.

Primary Outcome Measure

Change in gastrointestinal symptoms as assessed by the instrument Patient Assessment of upper Gastrointestinal Symptom Severity Index (PAGI-SYM) [ Time Frame: Change from baseline total PAGI-SYM score at end of therapy (6 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53226
Elaina Schueler, BA
[email protected]
Katja Kovacic, MD (PRINCIPAL_INVESTIGATOR)
Donald Basel, MD (SUB_INVESTIGATOR)
Matthew Plunk, MD (SUB_INVESTIGATOR)

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