Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome

A vizsgálat adatai

Ki végzi

Medical College of Wisconsin

Azonosító

NCT05212129

A regiszteradat frissítve

2026. február 13.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

Hypermobile Ehlers-Danlos Syndrome: Efficacy of Non-invasive Vagal Nerve Stimulation and Effects on Brain-Gut Physiology

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.

Bevonási feltételek: Children aged 10-18 years old; Children with functional upper GI complaints and clinical suspicion for hEDS or HSD as well as a Beighton score of at least 4/9; Children with functional upper GI complaints and clinical suspicion for ANS dysfunction; De-identified data from our prior studies (IRB #689519 and IRB #1064187) of patients with functional GI disorders who do NOT meet criteria for hEDS will be used as a comparison group; Children who are English-speaking and lack other explanation for symptoms; Children willing to participate and consent to this study (for children, have a parent willing to participate).

Kizáró feltételek: Patients who are treated with a new drug affecting the central nervous system in the two weeks prior to enrollment will also be excluded; Chronic alcohol/illicit drug use and/or smoking; Exclusion Criteria for subjects undergoing pVNS therapy:; Exclusion Criteria for subjects undergoing aVNS therapy:; Patients with pacemakers, metal clips used in previous surgery or other device which are not compatible with MRI scanning; Medically complex children or those who take a medication or suffer from a disease that can explain symptoms will be excluded from participation in the study; Patients with findings of organic disease such as peptic ulcer disease, H.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, metabolic disorder or any other chronic condition or medication that may cause chronic GI symptoms will be excluded from the study; Severe dermatological condition or active infection of external or middle ear; Seizure disorder; Egg allergy or anticipated inability to complete a standardized egg meal; Bleeding disorder for the specific biopsies; Exclusion Criteria applying to all participants:; Adult subjects, children or their parents who have significant developmental delay (will be excluded due to difficulties in accurately completing the questionnaires and assessing symptoms); Pregnancy (evaluating MD screens patients as they normally would during a clinic visit (by questioning) and would only perform urine pregnancy test if clinically indicated (absence of menstrual period or other symptoms concerning for pregnancy); Implanted electrical device; Hearing impaired; Sight impaired without correction; Exclusion Criteria for subjects undergoing gastric motor function sub-study:; Claustrophobia or inability to lie still in the scanner; Orthodontic braces or permanent retainers; Patients who are unable to tolerate noise produced by the MRI; Exclusion Criteria for subjects undergoing HepGI Biobank specimen collection sub-study:; Recent antibiotic usage for fecal sample; Significant anemia or clinical status which will not allow safe blood draw required for blood collection; Refusal of blood collection or to provide DNA sample; Inability or unwillingness on the individual (or parent/legal guardian) to provide clinical or family history.

ClinicalTrials.gov NCT05212129