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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorKing's College London

About this trial

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.

Eligibility criteria

Qualifiers

Between 18 and 80 years of age.

In the capacity to understand and sign an Informed Consent Form.

Willing and able to comply with scheduled visits and study procedures.

PoTS: following Heart Rhythm Society Expert Consensus Statement criteria, 2015, with or without comorbid FMS.

Disqualifiers

Previous diagnosis of an established autoimmune condition or dermatological conditions affecting skin afferents (e.g. psoriasis, lupus, vitiligo, dermatitis…).

Application of local anaesthetics or steroid injections within 35 days prior to the microneurography visit.

Current use of anticoagulant therapy.

History of peripheral neuropathy or conditions usually associated with peripheral neuropathy, such as Diabetes Mellitus, Vitamin B12 deficiency, Lyme disease, a screen positive for hepatitis B surface antigen, hepatitis C virus antibody, or antibodies against human immunodeficiency viruses 1 and 2.

Trial design

Treatments tested in this trial

  • Questionnaire and Physical Exam
  • Nerve conduction studies
  • Microneurography
  • Quantitative Sensory Testing
  • Skin biopsy
  • Blood Product

Treatment groups

250 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

King's College London

Lead sponsor

King's College Hospital NHS Trust

Collaborator

Guy's and St Thomas' NHS Foundation Trust

Collaborator