Clinical Trial

Auto-immune Contribution in Symptom-based Sensory and Autonomic Disorders

Study acronym: ACSSAD
Not Yet Recruiting
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Summary
Postural Orthostatic Tachycardia Syndrome (PoTS) is a condition where the heart rate increases when standing up, causing symptoms like dizziness and fainting. It primarily affects young women and can be very disabling, impacting daily life. In addition to the typical symptoms related to standing, people with PoTS also experience unexplained pain and fatigue, which worsen their quality of life. The exact causes of PoTS are still unknown, but it is often triggered by viral infections and some PoTS patients show signs of immune system involvement, such as the presence of certain autoantibodies and other autoimmune conditions. Research on other chronic pain disorders, including fibromyalgia syndrome (FMS), has found that autoantibodies can cause pain by affecting how the nerves work. This study aims to investigate if similar immune-related mechanisms are behind the widespread pain seen in PoTS. This study will also look at how PoTS affects the nervous system by testing nerve activity in participants and assessing the number of nerve fibres in the skin, to check if similar changes can be seen in mice. This study will also involve participants with fibromyalgia syndrome and healthy volunteers.
Trial Details
NCT Number NCT06992531
Lead Sponsor King's College London
Collaborators: King's College Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust
Conditions Postural Orthostatic Tachycardia Syndrome (POTS), Fibromyalgia (FM)
Enrollment 250 participants
Start Date 2025-10
Primary Completion 2029-10 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2025-05-28