Status:
NOT_YET_RECRUITING
Auto-immune Contribution in Symptom-based Sensory and Autonomic Disorders
Lead Sponsor:
King's College London
Collaborating Sponsors:
King's College Hospital NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Postural Orthostatic Tachycardia Syndrome (POTS)
Fibromyalgia (FM)
Eligibility:
All Genders
18-80 years
Brief 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 ...
Detailed Description
Postural orthostatic tachycardia syndrome (PoTS) is characterized by increased heart rate upon standing, light-headedness, and syncope. PoTS is a highly incapacitating condition affecting more than 0....
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06992531
Start Date
October 1 2025
End Date
October 1 2030
Last Update
May 28 2025
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