What side effects are associated with this type of intervention?

Non-invasive vagal nerve stimulation (nVNS) for Ehlers-Danlos Syndrome (EDS), particularly hypermobile EDS (hEDS), has been associated with mild side effects. These include a warm sensation, numbness in the arm or hand, redness, itching, tingling, muscle spasm, arm pain, shoulder pain, and neck pain. There have been no serious adverse events reported with the use of nVNS in the context provided. Other treatments for EDS may have different side effects, but the focus here is on the mild and generally well-tolerated side effects of nVNS.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Ehlers-Danlos Syndrome (EDS) that focus on non-invasive vagal nerve stimulation (nVNS) or similar neuromodulation techniques. Current research is exploring the potential benefits of nVNS for autonomic regulation and gastrointestinal symptoms in patients with hypermobile EDS, but these studies are still ongoing. Therefore, treatment for EDS primarily involves managing symptoms and associated conditions rather than targeting the underlying connective tissue disorder with FDA-approved neuromodulation therapies.

What other types of research exist?

Promising novel alternatives to non-invasive vagal nerve stimulation for Ehlers-Danlos Syndrome patients include: 1) Needle-less transcutaneous electrical stimulation (TEA) at ST36, which improves stress-induced impairment in gastric slow waves via autonomic mechanisms. 2) Gastric electrical stimulation, which has shown efficacy in treating refractory gastroparesis by reducing symptoms and hospitalizations. 3) Peroral endoscopic pyloromyotomy (POEM), which offers sustained symptom improvement for gastroparesis by addressing pylorospasm and reduced pyloric compliance.

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Vagal Nerve Stimulation for Ehlers-Danlos Syndrome

N/A

Recruiting

Led By Katja Kovacic, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at end of therapy (6 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two non-invasive treatments that stimulate the vagus nerve to help patients with Hypermobile Ehlers-Danlos Syndrome (hEDS) and Postural Orthostatic Tachycardia Syndrome (POTS). These patients often have severe stomach problems and issues with body regulation. The treatments aim to improve the function of the vagus nerve, which could reduce their symptoms and improve their quality of life. Non-invasive vagus nerve stimulation (nVNS) has been explored as a treatment for various conditions, including gastroparesis and functional dyspepsia, showing potential benefits in improving symptoms and gastric functions.

Who is the study for?

This trial is for children aged 10-18 with hypermobile Ehlers-Danlos Syndrome (hEDS) and related gastrointestinal or autonomic symptoms, who speak English and have a Beighton score of at least 4/9. It excludes those with seizure disorders, significant anemia, hearing impairment, complex medical conditions explaining their symptoms, recent CNS drug treatments, pregnancy, substance abuse issues, severe skin infections around the ear or incompatible implanted devices.

What is being tested?

The study tests two non-invasive vagal nerve stimulation therapies: percutaneous (pVNS) and acoustic (aVNS), to see if they can alleviate gastrointestinal symptoms in children with hEDS and Postural Orthostatic Tachycardia Syndrome by improving gastric function and autonomic signaling.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site for pVNS or hearing-related issues for aVNS. Since these are non-invasive methods, serious side effects are not common but could involve changes in heart rate or digestion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at end of therapy (6 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at end of therapy (6 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at end of therapy (6 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in gastrointestinal symptoms as assessed by the instrument Patient Assessment of upper Gastrointestinal Symptom Severity Index (PAGI-SYM)

Secondary study objectives

Change in Body Perception Questionnaire (BPQ) total score

Change in gastric motor function as assessed by gastric MRI

Change in vagal efficiency measurements

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Arm B (ANS Dysfunction)Experimental Treatment1 Intervention

(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.

Group II: Treatment Arm A (hEDS)Active Control1 Intervention

(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)

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Non-invasive vagal nerve stimulation (nVNS) is being studied as a treatment for Ehlers-Danlos Syndrome (EDS) due to its potential to modulate the autonomic nervous system and improve gastrointestinal function. The mechanism of action involves stimulating the vagus nerve, which can help regulate autonomic functions and reduce symptoms such as gastrointestinal dysmotility and postural orthostatic tachycardia syndrome (POTS). This is particularly important for EDS patients, who often suffer from autonomic dysfunction and related gastrointestinal issues. By improving autonomic regulation, nVNS may alleviate some of the debilitating symptoms associated with EDS, enhancing the quality of life for these patients.

Oesophageal reflex responses: abnormalities of the enteric nervous system in patients with oesophageal symptoms.Autonomic influences on colorectal motility and pelvic surgery.Vagal influence on the motility of the feline jejunum.