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Transcutaneous Auricular Neuromodulation for Ehlers-Danlos Syndrome (hEDS-tAN Trial)

N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mentally capable of reading, writing, giving consent, and following instructions
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

hEDS-tAN Trial Summary

This trial tests if using tAN at home on 30 hEDS patients can improve their physical and mental symptoms. Results are measured before, during and after a 4-week treatment.

Who is the study for?
This trial is for individuals with Hypermobile Ehlers-Danlos Syndrome or Hypermobility Spectrum Disorder who experience persistent symptoms in at least two areas such as pain, fatigue, sleep issues, anxiety, depression, and more. Participants must be able to read and write and follow instructions. Those with MRI-unsafe implants, seizure history or ear trauma are excluded.Check my eligibility
What is being tested?
The study tests if using a device for transcutaneous auricular neurostimulation at home can improve physical and psychological symptoms of hEDS/HSD patients. It's a randomized trial where half the participants will receive a sham (fake) treatment to compare results.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site on the ear or skin irritation from the device. Since it's non-invasive there are minimal risks compared to drug treatments but individual reactions can vary.

hEDS-tAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can read, write, give consent, and follow instructions.

hEDS-tAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ehlers-Danlos Syndrome Symptom Battery

hEDS-tAN Trial Design

2Treatment groups
Experimental Treatment
Group I: Four Weeks of Active Transcutaneous Auricular NeurostimulationExperimental Treatment1 Intervention
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)
Group II: 2 Weeks Sham tAN followed by 2 Weeks Active tANExperimental Treatment1 Intervention
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).

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Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,606 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the eligibility criteria for this clinical trial?

"This clinical trial is accepting a total of 30 patients with Ehlers-Danlos Syndrome between the ages 18 and 65."

Answered by AI

Is there an age cap for eligibility in this research experiment?

"The study mandates that individuals between the age of 18 and 65 may participate. Nonetheless, there are 375 studies available for minors and 1,056 trials accessible to those above the traditional retirement age."

Answered by AI

Are there any vacancies for subjects in this research endeavor?

"Confirmed. According to the data on clinicaltrials.gov, this experiment is currently enrolling participants since its original posting date of July 5th 2023. The study requires 30 patients from a single site and was last updated on October 26th 2023."

Answered by AI

How many individuals are actively involved in this experimental exploration?

"Affirmative, clinicaltrials.gov lists the trial as actively recruiting patients since it was first posted on July 5th 2023 and last edited October 26th 2023. This study requires 30 participants from a single location to complete the trial."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Hypermobile Ehlers-Danlos Syndrome - Transcutaneous Auricular Neuromodulation
Bashar Badran 2023. "Hypermobile Ehlers-Danlos Syndrome - Transcutaneous Auricular Neuromodulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06105541.
~18 spots leftby Jul 2025
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