Vagal Nerve Stimulation for Ehlers-Danlos Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byKatja Kovacic, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical College of Wisconsin

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Information from our previous studies of patients with stomach and digestive issues who don't have a specific condition called hEDS will be used for comparison.

Kids between 10 and 18 years old

Kids who speak English and don't have another reason for their symptoms.

+4 more

Exclusion Criteria

Refusal of blood collection or to provide DNA sample

You have a history of seizures.

You have severe anemia or a medical condition that makes drawing blood unsafe.

+18 more

Participant Groups

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.

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)