Hypermobile Ehlers-Danlos Syndrome - Transcutaneous Auricular Neuromodulation

Description

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.

Conditions

Hypermobile Ehlers-Danlos Syndrome, Hypermobile Spectrum Disorder, Ehlers-Danlos Syndrome

Study Overview

Study Details

Study overview

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.

At-Home Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome

Hypermobile Ehlers-Danlos Syndrome - Transcutaneous Auricular Neuromodulation

Condition
Hypermobile Ehlers-Danlos Syndrome
Intervention / Treatment

-

Contacts and Locations

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * MRI-contraindicated implanted medical devices;
  • * pregnant
  • * history of seizures
  • * prior history of trauma or damage to ear

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical University of South Carolina,

Study Record Dates

2025-07-01