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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
Study Summary
This trial will study the clinical relationship between hEDS/Hypermobile Spectrum Disorders and autonomic regulation and see if vagal nerve stimulation therapies can reduce GI symptoms in hEDS and POTS.
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.Check my eligibility
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.See study design
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in gastrointestinal symptoms as assessed by the instrument Patient Assessment of upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Secondary outcome measures
Change in Body Perception Questionnaire (BPQ) total score
Change in gastric motility function as assessed by gastric MRI motility index
Change in respiratory sinus arrhythmia measurements
+1 moreTrial 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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Who is running the clinical trial?
University College, LondonOTHER
833 Previous Clinical Trials
38,910,299 Total Patients Enrolled
2 Trials studying Ehlers-Danlos Syndrome
85 Patients Enrolled for Ehlers-Danlos Syndrome
Indiana UniversityOTHER
980 Previous Clinical Trials
982,892 Total Patients Enrolled
1 Trials studying Ehlers-Danlos Syndrome
3,000 Patients Enrolled for Ehlers-Danlos Syndrome
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,493 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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 oldYou have a history of seizures.Kids who speak English and don't have another reason for their symptoms.Information from past studies of patients with stomach and intestine problems who don't have a specific condition will be used for comparison.You have severe anemia or a medical condition that makes drawing blood unsafe.Children who have stomach problems and may have issues with their nervous system.You have trouble hearing.You are afraid of small spaces or cannot stay still during a scan.You cannot handle the loud sounds made by the MRI machine.You are allergic to eggs or may not be able to eat a regular egg meal.You have a bleeding disorder that would make it unsafe for you to have certain types of biopsies.You have recently taken antibiotics before providing a stool sample.Children with complicated medical conditions or who are taking medication that could explain their symptoms will be excluded.Adults, children, or their parents who have important difficulties with learning or growing.You have a chronic stomach or intestinal condition or take medications that can cause ongoing stomach or intestinal problems.You have taken a new medication that affects the brain in the two weeks before joining the study.You regularly drink a lot of alcohol, use illegal drugs, or smoke cigarettes.You have a serious skin condition or an active infection in your outer or middle ear.You have a medical device implanted in your body that uses electricity.You have trouble seeing even with glasses or contacts.Children with stomach or esophagus problems and suspected joint hypermobility or hypermobility spectrum disorder, with a Beighton score of at least 4 out of 9.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm B (ANS Dysfunction)
- Group 2: Treatment Arm A (hEDS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must a patient satisfy in order to be enrolled in this clinical trial?
"This medical study seeks to enroll 90 participants, between the ages of 10 and 18 years old, with an existing diagnosis of postural orthostatic tachycardia syndrome."
Answered by AI
Does eligibility for this experiment extend to elderly participants?
"According to the study's requirements, individuals between 10 and 18 can apply. There are currently 426 trials available for minors while 1,236 cater exclusively to individuals 65 years or older."
Answered by AI
Is this clinical trial still open to participants?
"According to clinicaltrials.gov, which last updated the study on January 26th 2022, this trial is actively seeking participants since its initial posting of April 5th 2021."
Answered by AI
What is the upper limit of participants involved in this experiment?
"Affirmative. As per the information posted on clinicaltrials.gov, this ongoing medical trial is actively seeking participants with a recruitment target of 90 patients from 1 site. It was initially publicised on April 5th 2021 and updated most recently January 26th 2022."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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