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

Launched by KING'S COLLEGE LONDON · May 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying Postural Orthostatic Tachycardia Syndrome (PoTS) and Fibromyalgia (FM), two conditions that can cause significant pain and discomfort. PoTS is a condition where your heart races when you stand up, leading to symptoms like dizziness and fainting, while FM is characterized by widespread pain and fatigue. The researchers want to learn more about how the immune system might be involved in these conditions, especially since some patients show signs of immune activity. They will test nerve function and look at skin nerve fibers in participants to see if similar changes occur in both people and mice.

To participate in this study, you should be between 18 and 80 years old and willing to follow the study procedures. You would need a diagnosis of PoTS or FM, or you could be a healthy volunteer without any chronic pain or autoimmune conditions. Participants will have scheduled visits where they might undergo tests to understand their nerve activity better. It's important to note that certain health conditions or recent treatments could exclude someone from participating. Overall, this study aims to uncover more about these complex conditions and potentially improve how they are understood and treated.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• * Diagnostic criteria for participants:
• • PoTS: following Heart Rhythm Society Expert Consensus Statement criteria, 2015, with or without comorbid FMS.
• • FMS: following the American College of Rheumatology criteria 2016, with Fibromyalgia Impact Questionnaire (FIQ) exceeding 50, and with an average pain intensity exceeding 5.5.
• • Healthy volunteers: no diagnosed autoimmune, chronic pain, or dysautonomia condition.
• Exclusion Criteria:
• • 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.
• • Pregnancy.
• • Difficulties in locating the nerve (i.e. nerve cannot be seen or palpated) or previously known trauma or surgery in the area innervated will be a criterion for the exclusion of the participant for this part of the study.
• • History of regular alcohol consumption (exceeding 14 units per week) or recent alcohol consumption exceeding 14 units per week over the last 6 months (14 units is equivalent to 7 pints \[568 mL/pint\] of beer at 3.6% alcohol by volume or 6 standard glasses \[176 mL/glass\] of wine at 12% alcohol by volume).
• • Excessive consumption of caffeinated beverages (e.g., coffee, tea, cola, energy drinks), is defined as greater than 6 servings per day (1 serving/236 mL equals approximately 120 mg of caffeine).
• • A history of drug abuse or addiction within 2 years before study, current regular or recreational use of marijuana (or any cannabis derivative).