Using ear stimulation to improve symptoms in patients with Hypermobile Ehlers-Danlos Syndrome
At-Home Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome
This study is testing if a device that stimulates nerves in the ear can help people with Hypermobile Ehlers-Danlos Syndrome feel better by reducing pain, fatigue, and other symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (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 | NCT06105541 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous auricular neurostimulation (tAN) on various physical and psychological symptoms in patients with Hypermobile Ehlers-Danlos Syndrome (hEDS) and Hypermobile Spectrum Disorder (HSD). A total of 30 participants will undergo a randomized, double-blind, sham-controlled intervention over a four-week period, with assessments conducted at baseline, after the intervention, and three months post-intervention. The study aims to evaluate improvements in pain, fatigue, sleep, anxiety, depression, quality of life, gastrointestinal function, immune function, and autonomic function. The tAN device used is FDA-cleared and targets specific nerves in the ear to provide therapeutic stimulation.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with hEDS or HSD who experience persistent symptoms in at least two of the targeted domains.
Not a fit: Patients with MRI-contraindicated implanted medical devices, those who are pregnant, have a history of seizures, or have prior trauma to the ear may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly alleviate symptoms and improve the quality of life for patients suffering from hEDS and HSD.
How similar studies have performed: Previous studies have shown that transcutaneous auricular neurostimulation can effectively reduce pain associated with opioid withdrawal, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: * MRI-contraindicated implanted medical devices; * pregnant * history of seizures * prior history of trauma or damage to ear
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- 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.