Status:
ACTIVE_NOT_RECRUITING
Hypermobile Ehlers-Danlos Syndrome - Transcutaneous Auricular Neuromodulation
Lead Sponsor:
Medical University of South Carolina
Conditions:
Hypermobile Ehlers-Danlos Syndrome
Hypermobile Spectrum Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Investigate whether at-home transcutaneous auricular VNS (tAN: transcutaneous auricular neurostimulation) improves a battery of nine key physical and psychological symptoms of a group of hEDS (Hypermo...
Detailed Description
The intervention we are studying is called transcutaneous auricular neurostimulation (tAN). tAN is simply electrical nerve stimulation administered at the ear which targets both the auricular branch o...
Eligibility Criteria
Inclusion
- 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
- MRI-contraindicated implanted medical devices;
- pregnant
- history of seizures
- prior history of trauma or damage to ear
Key Trial Info
Start Date :
July 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06105541
Start Date
July 5 2023
End Date
February 4 2026
Last Update
December 9 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425