Out-of-State, At-Home, Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Hypermobile EDS and hypermobile spectrum disorder (collectively referred to as hEDS) are estimated to affect 1 in 500 individuals worldwide. hEDS patients have limited treatment options for their numerous symptoms that impact the quality of life. This clinical trial tests a new ear stimulation method in hEDS patients to determine if it may improve quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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;

Locations
United States
South Carolina
Medical University of South Carolina Institute of Psychiatry
RECRUITING
Charleston
Contact Information
Primary
Katherine Tucker
tuckekat@musc.edu
843-792-9502
Time Frame
Start Date: 2024-11-27
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 36
Treatments
Experimental: Four Weeks of Active Transcutaneous Auricular Neurostimulation
Participants will receive 4 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN).
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: MUSC Blue Sky initiative

This content was sourced from clinicaltrials.gov