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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.
Vascular Ehlers-Danlos Syndrome (VEDS) is caused by pathogenic variants of the COL3A1 gene, resulting abnormal Type III collagen protein. This impacts the body's connective tissue and makes people with VEDS at high risk of spontaneous aortic and arterial rupture, pneumothorax, and hollow organ perforation across the age spectrum. Given this risk and high potential for lethality, VEDS is considered the most severe type of Ehlers-Danlos Syndrome. In addition, many patients experience chronic pain and fatigue, sleep disturbances, and mental health challenges. As is the case for many patients with chronic illness, stress, anxiety, and depression are often present over the course of the disease. Despite the antecedent, stress and anxiety trigger a sympathetic nervous system (SNS) response in the body, which, over a period of time, can have detrimental effects both physiologically and psychologically for patients. Recent studies have begun to use biofeedback techniques to teach patients non-pharmacological strategies for managing their autonomic nervous system. One such program, Heartmath®, has been successful in helping patients lower stress, anxiety, and systolic blood pressure. This pilot trial was established to assess the effectiveness of a virtually based heart coherence program in a population with a chronic aortopathy in an effort to establish a larger, multi-provider program that also encompasses other cardiovascular populations.
Chronic pain is a major complaint among many individuals living with hypermobile Ehlers Danlos Syndrome (hEDS) and may have a severe impact on quality of life and activities of daily living. Given the complexity of the disease's pathophysiology, effective treatments are limited. This investigation will examine the impacts of green light exposure on subject-reported pain severity and symptoms. Knowing whether this intervention can improve pain and quality of life in this population may offer valuable guidance to clinicians who treat hEDS patients and to hEDS patients themselves.
This is a prospective, Phase 3, randomized, double-blind, placebo-controlled efficacy study to evaluate celiprolol in patients genetically confirmed as COL3A1-positive vEDS using a decentralized clinical trial design.
Hypermobile Ehlers-Danlos Syndrome (hEDS) is a connective tissue disorder characterized by hyperextensible skin, joint hypermobility and additional connective tissue manifestations. For unclear reasons, hEDS is associated with many gastrointestinal (GI) and autonomic nervous system (ANS) complaints such as postural orthostatic tachycardia syndrome (POTS). This study will address the clinical relationship between hEDS/Hypermobile Spectrum Disorders and autonomic regulation and see if there is a benefit of two forms of non-invasive vagal nerve stimulation therapies to reduce GI symptoms in hEDS and POTS. The study will also investigate plausible effects of these nerve stimulation therapies on gastric function and autonomic signaling.
In this study, researchers want to learn about the connection between heavy bleeding issues and joint hypermobility (loose joints). They want to know if these issues may indicate other connective tissue problems in girls and women with heavy menstrual bleeding who do not have a known cause. Primary Objective * Compare the severity of heavy menstrual bleeding (HMB) in women with and without Generalized joint Hypermobility Syndrome Disorder/hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using bleeding scores. Secondary Objectives * Compare the frequency of co-morbidities in women with and without G-HSD/hEDS.
FLOWER is a completely virtual, nationwide, real-world observational study to collect, annotate, standardize, and report clinical data for rare diseases. Patients participate in the study by electronic consent (eConsent) and sign a medical records release to permit data collection. Medical records are accessed from institutions directly via eFax or paper fax, online from patient electronic medical record (EMR) portals, direct from DNA/RNA sequencing and molecular profiling vendors, and via electronic health information exchanges. Patients and their treating physicians may also optionally provide medical records. Medical records are received in or converted to electronic/digitized formats (CCDA, FHIR, PDF), sorted by medical record type (clinic visit, in-patient hospital, out-patient clinic, infusion and out-patient pharmacies, etc.) and made machine-readable to support data annotation, full text searches, and natural language processing (NLP) algorithms to further facilitate feature identification.
The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. "Healthy" individuals without brain inflammation are also eligible to participate. The digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.
The main purpose of this study is to define the complex genetic and pathogenic basis of thoracic aortic aneurysm (TAA) and other forms of aortopathy and/or aortic valve disease by identifying novel disease-causing genes and by identifying important genetic modifiers for aortic and aortic valve disease severity.
The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.