RECRUITING

Out of State - tAN hEDS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-25
Study Completion:2025-08-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06548594

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages of 18 and 65;
  2. * 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)
  3. * Mentally capable of reading, writing, giving consent, and following instructions;
  1. * Mentally capable of reading, writing, giving consent, and following instructions;
  2. * Not pregnant;
  3. * No history of seizures;
  4. * no prior history of trauma or damage to ear
  5. * History of documented Autism spectrum disorder (ASD) diagnosis
  6. * Residing in the state of South Carolina

Contacts and Locations

Study Contact

Katherine Tucker
CONTACT
843-792-9502
tuckekat@musc.edu

Principal Investigator

Bashar Badran
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Bashar Badran, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-25
Study Completion Date2025-08-05

Study Record Updates

Study Start Date2024-11-25
Study Completion Date2025-08-05

Terms related to this study

Keywords Provided by Researchers

  • Brain

Additional Relevant MeSH Terms

  • Hypermobile EDS (hEDS)