CompletedNot Applicable

Hypermobile Ehlers-Danlos Syndrome - Transcutaneous Auricular Neuromodulation

United States25 participantsStarted 2023-07-05

Plain-language 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 (Hypermobile Ehlers-Danlos Syndrome \& Hypermobile Spectrum Disorder) patients (n=30) using a randomized, double blind, sham controlled design. The study team will collect clinical measures at baseline, after a two-week double-blind intervention phase, after a following two-week open-label phase and finally at three months post intervention. The study team will test patients in the following domains: pain, fatigue, sleep, anxiety, depression, quality of life, GI function, immune function and autonomic function.

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

Ehlers-Danlos Syndrome Symptom Battery

Timeframe: 16 weeks

Trial details

NCT IDNCT06105541

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-04

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