Testing ear stimulation for improving quality of life in hypermobile EDS patients
Out-of-State, At-Home, Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome
This study is testing a new ear stimulation method to see if it can help improve the quality of life for adults with hypermobile Ehlers-Danlos syndrome and related conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06548594 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a new method of ear stimulation, known as Transcutaneous Auricular Neurostimulation, to assess its effectiveness in improving the quality of life for patients with hypermobile Ehlers-Danlos syndrome (hEDS) and hypermobility spectrum disorder (HSD). The study focuses on individuals aged 18 to 65 who meet specific diagnostic criteria and experience persistent symptoms across various domains such as pain, fatigue, and anxiety. By targeting the vagus nerve, the intervention aims to alleviate some of the debilitating symptoms associated with hEDS. Participants will be monitored throughout the intervention to evaluate changes in their symptoms and overall well-being.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who have been diagnosed with hEDS or HSD and experience persistent symptoms.
Not a fit: Patients who do not meet the diagnostic criteria for hEDS or HSD, or those with certain exclusions such as a history of seizures or residing outside South Carolina, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a new treatment option that significantly improves the quality of life for patients suffering from hEDS.
How similar studies have performed: While this approach is novel in the context of hEDS, similar neurostimulation techniques have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages of 18 and 65; * Participants who meet the 2017 diagnostic criteria for hEDS or HSD4-5 with persistent symptoms in at least two of the domains to be followed during the intervention (pain, fatigue, sleep, anxiety, depression, quality of life, GI function, autonomic function and immune function) * Mentally capable of reading, writing, giving consent, and following instructions; Exclusion Criteria: * Mentally capable of reading, writing, giving consent, and following instructions; * Not pregnant; * No history of seizures; * no prior history of trauma or damage to ear * History of documented Autism spectrum disorder (ASD) diagnosis * Residing in the state of South Carolina
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina Institute of Psychiatry — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Borckardt, PhD — Medical University of South Carolina
- Study coordinator: Katherine Tucker
- Email: tuckekat@musc.edu
- Phone: 843-792-9502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.