RECRUITING

Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome

Talk to us

Conditions

Functional Gastrointestinal DisordersHypermobile Ehlers-Danlos SyndromePostural Orthostatic Tachycardia SyndromeAutonomic Nervous System DiseaseAutonomic Nervous System Imbalance

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-04-05
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05212129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Children aged 10-18 years old
  2. * Children with functional upper GI complaints and clinical suspicion for hEDS or HSD as well as a Beighton score of at least 4/9
  3. * Children with functional upper GI complaints and clinical suspicion for ANS dysfunction
  4. * 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
  5. * Children who are English-speaking and lack other explanation for symptoms
  6. * Children willing to participate and consent to this study (for children, have a parent willing to participate)
  1. * 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.
  2. * 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)
  3. * 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.
  4. * Patients who are treated with a new drug affecting the central nervous system in the two weeks prior to enrollment will also be excluded.
  5. * 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)
  6. * Chronic alcohol/illicit drug use and/or smoking.
  7. * Severe dermatological condition or active infection of external or middle ear
  8. * Implanted electrical device
  9. * Hearing impaired
  10. * Sight impaired without correction
  11. * Seizure disorder
  12. * Patients with pacemakers, metal clips used in previous surgery or other device which are not compatible with MRI scanning
  13. * Claustrophobia or inability to lie still in the scanner
  14. * Orthodontic braces or permanent retainers
  15. * Patients who are unable to tolerate noise produced by the MRI
  16. * Egg allergy or anticipated inability to complete a standardized egg meal
  17. * Bleeding disorder for the specific biopsies
  18. * Recent antibiotic usage for fecal sample
  19. * Significant anemia or clinical status which will not allow safe blood draw required for blood collection
  20. * Refusal of blood collection or to provide DNA sample
  21. * Inability or unwillingness on the individual (or parent/legal guardian) to provide clinical or family history.

Contacts and Locations

Study Contact

Katja Kovacic, MD
CONTACT
(414) 266-3690
kkovacic@mcw.edu
Monica Grimm, BA
CONTACT
(414) 266-6111
mgrimm@mcw.edu

Principal Investigator

Katja Kovacic, MD
PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin

Study Locations (Sites)

Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

  • Katja Kovacic, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-05
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-04-05
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

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