Out of State - tAN hEDS

NCT06548594 | Active Not Recruiting

• 1 other identifier: Pro00138254
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypermobile EDS (hEDS)

Keywords

Brain

Outcome Measures

Primary Outcomes (1)

• Ehlers-Danlos Syndrome Symptom Battery

  The investigators have created an Ehlers-Danlos Syndrome Symptom Battery that measures a variety of different primary and secondary symptoms associated with Ehlers-Danlos Syndrome, including: Pain, Fatigue, Sleep, Anxiety, Depression, Quality of Life, and Gastrointestinal issues.

  4 weeks

Study Arms (1)

Four Weeks of Active Transcutaneous Auricular Neurostimulation

EXPERIMENTAL

Participants will receive 4 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN).

Device: Transcutaneous Auricular Neurostimulation

Interventions

Transcutaneous Auricular Neurostimulation DEVICE

Transcutaneous Auricular Neurostimulation (tAN) is a wearable, electrical stimulation device that delivers electricity to specific parts of the human ear.

Four Weeks of Active Transcutaneous Auricular Neurostimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Mentally capable of reading, writing, giving consent, and following instructions;
• Not pregnant;
• No history of seizures;
• no prior history of trauma or damage to ear
• History of documented Autism spectrum disorder (ASD) diagnosis
• Residing in the state of South Carolina

Sponsors & Collaborators

• Medical University of South Carolina: lead
• MUSC Blue Sky initiative: collaborator

Study Sites (1)

Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3

Study Officials

• Jeffrey Borckardt, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: November 27, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-10

Locations

US (1)