Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome

Functional Gastrointestinal Disorders Clinical Trial

Official title: Hypermobile Ehlers-Danlos Syndrome: Efficacy of Non-invasive Vagal Nerve Stimulation and Effects on Brain-Gut Physiology

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 and Hypermobile Spectrum Disorders are associated with many gastrointestinal (GI) and autonomic nervous system (ANS) complaints such as postural orthostatic tachycardia syndrome (POTS). Symptoms are often disabling and associated with poor quality of life and high health care costs. The proposed research will address the following understudied areas: 1) the clinical relationship between hEDS and autonomic regulation, 2) the potential benefit of two forms of non-invasive vagal nerve stimulation (VNS) therapies in reducing functional GI symptoms in hEDS and POTS, and 3) plausible effects of these VNS therapies on gastric motor function and neurohormonal signaling. Clinical reports document a high co-morbidity between autonomic disorders and hEDS. This prospective study will focus on three major clinical questions: 1) Are there reliable neurophysiological markers associated with hEDS that can provide insights into the 'neural mechanisms' resulting in multisystem co-morbidities? 2) Will innovative intervention techniques designed to enhance autonomic regulation via two non-invasive vagal nerve stimulation techniques (e.g., auricular and acoustic VNS) provide substantial symptom reduction and improve the hEDS patients' quality of life? 3) Can a novel gastric MRI technique capture gastric motor function abnormalities in adolescents with hEDS? ;

Related Conditions & MeSH terms

• Autonomic Nervous System Disease
• Autonomic Nervous System Diseases
• Autonomic Nervous System Imbalance
• Digestive System Diseases
• Ehlers-Danlos Syndrome
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Hypermobile Ehlers-Danlos Syndrome
• Nervous System Diseases
• Postural Orthostatic Tachycardia Syndrome
• Primary Dysautonomias
• Syndrome
• Tachycardia

• NCT number: NCT05212129
• Study type: Interventional
• Source: Medical College of Wisconsin
• Contact: Katja Kovacic, MD
• Phone: (414) 266-3690
• Email: kkovacic@mcw.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2021
• Completion date: December 31, 2023