Hypermobile Ehlers-Danlos Syndrome - Transcutaneous Auricular Neuromodulation

NCT06105541 | Completed DMC FDA Device

• 1 other identifier: Pro00128818
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 (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

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

  16 weeks

Study Arms (2)

2 Weeks Sham tAN followed by 2 Weeks Active tAN

EXPERIMENTAL

Participants will be randomized to receive 2 weeks of at-home, self-administered sham Transcutaneous Auricular Neurostimulation (tAN), followed by 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN).

Device: Transcutaneous Auricular Neurostimulation

Four Weeks of Active Transcutaneous Auricular Neurostimulation

EXPERIMENTAL

Participants will be randomized to receive 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN), followed by 2 additional 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.

2 Weeks Sham tAN followed by 2 Weeks Active tAN; 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:

• 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:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3; Ehlers-Danlos Syndrome

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Model Details: Participants will be randomized to one of two paralell groups: Group 1: Double-blind phase Active, Open-label phase Active Group 2: Double-blind phase Sham, Open-label phase Active

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: October 27, 2023
• Study Start: July 5, 2023
• Primary Completion: February 4, 2026
• Study Completion: February 4, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-10

Locations

US (1)