Postural Orthostatic Tachycardia Syndrome (POTS)ACSSADNCT06992531
Auto-immune Contribution in Symptom-based Sensory and Autonomic Disorders
An observational study of Postural Orthostatic Tachycardia Syndrome (POTS) and Fibromyalgia (FM), run by King's College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome (POTS), Fibromyalgia (FM)
- What is being tested?
- Questionnaire and Physical Exam, Nerve conduction studies and Microneurography
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 patients diagnosed with PoTS (50% with comorbid FMS) 50 patients diagnosed with FMS without dysautonomia Up to 100 healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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 0.2% of the population worldwide, mostly young women. The causes of this syndrome remain unknown and are still discussed, leading to unsatisfactory diagnostic tools and a delay in the recognition of PoTS as a medical condition with clear biomarkers.
The onset of postural orthostatic tachycardia symptoms is often associated with traumatic episodes or acute viral infections. An increase in PoTS diagnostic has notably been observed in adults and children during the SARS-CoV-2 epidemic. Moreover, some characteristics present in a subset of patients, namely the presence of anti-nuclear antibodies, or ganglionic acetylcholine receptor immunoglobulins, and the high prevalence of comorbid auto-immune conditions, suggest a fundamental role of the immune system in the development of PoTS.
PoTS patients report symptoms unrelated to orthostatic intolerance, including widespread pain, muscle weakness and fatigue, which remain unexplained. These symptoms contribute to lower quality of life and impair patients' daily life.
Our group has a longstanding experience in the study of widespread pain conditions linked with autoimmunity. We have recently shown that the administration of immunoglobulins purified from fibromyalgia syndrome (FMS) and chronic regional pain syndrome (CRPS) patients replicates painful and non-painful phenotypes in mice. In contrast with the CRPS mice, where a physical injury is needed to induce hypersensitivity, intraperitoneal administration of IgG was sufficient to generate mechanical hyperalgesia and abnormal responses to non-noxious stimuli in rodents.
The passive transfer of fibromyalgia symptoms from patients to mice via IgG administration presents many advantages, amongst which is the possibility of studying immune-mediated neuronal abnormalities in isolation. Upon FMS IgG administration, we observed an accumulation of pathological IgG in dorsal root ganglia (DRG), the organs relaying sensory information perceived in peripheral organs, to the spinal cord. Interestingly, the exploration of murine DRGs cells signalling revealed an increased activity of sensory neurons, canonically responsible for mechanical and thermal sensations, but also for the perception of painful stimuli. This enhanced activity was not observed with preparation isolated from mice injected with healthy volunteer immunoglobulins.
This study has revealed immune-mediated mechanisms leading to hyperexcitability in sensory neurons and causing exacerbated pain and non-painful perception in fibromyalgia. We now intend to assess whether widespread pain, observed in PoTS patients presents a similar autoimmune pathophysiology. Moreover, we aim to investigate potential abnormalities of the autonomic system caused by the administration of PoTS IgG.
- Being tested
- Questionnaire and Physical Exam, Nerve conduction studies, Microneurography, Quantitative Sensory Testing, Skin biopsy
- Keywords
- Postural orthostatic Tachycardia Syndrome, Fibromyalgia Syndrome, Widespread pain, Autoantibodies, Autonomic and sensory functions
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
Standardised participant questionnaires assessing neurological symptoms, including pain (NPSI, DN4, BPI), fatigue (Fatigue Severity Scale), depression and anxiety (PHQ9 and GAD7) and autonomic dysfunction (Malmo PoTS Score and COMPASS-31).
Nerve conduction studiesDiagnostic test
Measures how fast an electrical impulse moves through sensory and motor nerves. The test will be used to identify/rule out large fibre peripheral neuropathy.
MicroneurographyDiagnostic test
Electrophysiological technique that can record action potentials from individual peripheral nerve axons in humans. The test will be used to identify/rule out small nerve fibre dysfunction.
Quantitative Sensory TestingDiagnostic test
Measures psychophysical sensory perception in response to different types of stimuli, such as thermal, mechanical, pressure and vibration. The test will be used to identify/rule out nerve fibre dysfunction, by generating a quantitative sensory profile of different sensory modalities.
Skin biopsyDiagnostic test
Safe and minimally invasive procedure to quantify intraepidermal nerve fibres density (IENFD). Reduced IENF density is associated with small fibre neuropathy.
Blood ProductBiological
A blood sample of a maximum of 120ml will be collected from a superficial upper limb vein. Blood aliquots (50ml tubes) will then be centrifuged to separate serum from the peripheral blood cells.
| Study group | Role | What they receive |
|---|---|---|
| PoTS with pain | Participants with PoTS with an additional diagnosis of FMS Receives: Other: Questionnaire and Physical Exam; Diagnostic Test: Nerve conduction studies; Diagnostic Test: Microneurography; Diagnostic Test: Quantitative Sensory Testing; Diagnostic Test: Skin biopsy; Biological: Blood Product | |
| PoTS without pain | Participants with PoTS without pain Receives: Other: Questionnaire and Physical Exam; Diagnostic Test: Nerve conduction studies; Diagnostic Test: Microneurography; Diagnostic Test: Quantitative Sensory Testing; Diagnostic Test: Skin biopsy; Biological: Blood Product | |
| FMS | Participants with FMS without dysautonomia Receives: Other: Questionnaire and Physical Exam; Diagnostic Test: Nerve conduction studies; Diagnostic Test: Microneurography; Diagnostic Test: Quantitative Sensory Testing; Diagnostic Test: Skin biopsy; Biological: Blood Product | |
| Healthy volunteers | Healthy volunteers with no diagnosed autoimmune, chronic pain, or dysautonomia condition. Receives: Other: Questionnaire and Physical Exam; Diagnostic Test: Nerve conduction studies; Diagnostic Test: Microneurography; Diagnostic Test: Quantitative Sensory Testing; Diagnostic Test: Skin biopsy; Biological: Blood Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of immune-mediated pain mechanisms and autonomic dysfunction
To determine whether IgG antibodies from PoTS participants (with or without FMS) induce pain-like behaviours and autonomic abnormalities in mice, following passive transfer.
Measured: From enrollment until passive tranfer experiments are performed.
Secondary outcomes (4)
Assessment of electrical activity recorded from nerve fibres in humans
To use microneurography to measure nerve activity in participants and identify patterns consistent with small nerve fibre dysfunction.
Measured: From enrollment until Visit 1.
Evidence of small fibre neuropathy (SFN)
To evaluate intra-epidermal nerve fibre density (IENFD) in skin biopsies from PoTS participants to identify signs of SFN; similar analysis will be conducted in mice receiving participants' IgG.
Measured: From enrollment until passive tranfer experiments are performed.
IgG binding to rodent neurons
To test whether IgG from participants' serum binds to neurons in vitro, using cell-based assays and immunofluorescence.
Measured: From enrollment until passive tranfer experiments are performed.
Correlation between participants symptoms and IgG effects in mice
To explore whether clinical symptom severity (e.g., pain, autonomic dysfunction) correlates with the degree of abnormality observed in mice after IgG transfer.
Measured: From enrollment until passive tranfer experiments are performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Orthostatic Tachycardia Syndrome (POTS)Studies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992531
- Sponsor's protocol ID
- 352817
- Acronym
- ACSSAD
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auto-immune Contribution in Symptom-based Sensory and Autonomic Disorders
- ClinicalTrials.gov ID
- NCT06992531
- Acronym / sponsor ID
- ACSSAD / 352817
- Keywords
- Postural orthostatic Tachycardia Syndrome, Fibromyalgia Syndrome, Widespread pain, Autoantibodies, Autonomic and sensory functions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 0.2% of the population worldwide, mostly young women. The causes of this syndrome remain unknown and are still discussed, leading to unsatisfactory diagnostic tools and a delay in the recognition of PoTS as a medical condition with clear biomarkers.
The onset of postural orthostatic tachycardia symptoms is often associated with traumatic episodes or acute viral infections. An increase in PoTS diagnostic has notably been observed in adults and children during the SARS-CoV-2 epidemic. Moreover, some characteristics present in a subset of patients, namely the presence of anti-nuclear antibodies, or ganglionic acetylcholine receptor immunoglobulins, and the high prevalence of comorbid auto-immune conditions, suggest a fundamental role of the immune system in the development of PoTS.
PoTS patients report symptoms unrelated to orthostatic intolerance, including widespread pain, muscle weakness and fatigue, which remain unexplained. These symptoms contribute to lower quality of life and impair patients' daily life.
Our group has a longstanding experience in the study of widespread pain conditions linked with autoimmunity. We have recently shown that the administration of immunoglobulins purified from fibromyalgia syndrome (FMS) and chronic regional pain syndrome (CRPS) patients replicates painful and non-painful phenotypes in mice. In contrast with the CRPS mice, where a physical injury is needed to induce hypersensitivity, intraperitoneal administration of IgG was sufficient to generate mechanical hyperalgesia and abnormal responses to non-noxious stimuli in rodents.
The passive transfer of fibromyalgia symptoms from patients to mice via IgG administration presents many advantages, amongst which is the possibility of studying immune-mediated neuronal abnormalities in isolation. Upon FMS IgG administration, we observed an accumulation of pathological IgG in dorsal root ganglia (DRG), the organs relaying sensory information perceived in peripheral organs, to the spinal cord. Interestingly, the exploration of murine DRGs cells signalling revealed an increased activity of sensory neurons, canonically responsible for mechanical and thermal sensations, but also for the perception of painful stimuli. This enhanced activity was not observed with preparation isolated from mice injected with healthy volunteer immunoglobulins.
This study has revealed immune-mediated mechanisms leading to hyperexcitability in sensory neurons and causing exacerbated pain and non-painful perception in fibromyalgia. We now intend to assess whether widespread pain, observed in PoTS patients presents a similar autoimmune pathophysiology. Moreover, we aim to investigate potential abnormalities of the autonomic system caused by the administration of PoTS IgG.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PoTS with pain | – | Other: Questionnaire and Physical Exam, Diagnostic Test: Nerve conduction studies, Diagnostic Test: Microneurography, Diagnostic Test: Quantitative Sensory Testing, Diagnostic Test: Skin biopsy, Biological: Blood ProductParticipants with PoTS with an additional diagnosis of FMS |
| PoTS without pain | – | Other: Questionnaire and Physical Exam, Diagnostic Test: Nerve conduction studies, Diagnostic Test: Microneurography, Diagnostic Test: Quantitative Sensory Testing, Diagnostic Test: Skin biopsy, Biological: Blood ProductParticipants with PoTS without pain |
| FMS | – | Other: Questionnaire and Physical Exam, Diagnostic Test: Nerve conduction studies, Diagnostic Test: Microneurography, Diagnostic Test: Quantitative Sensory Testing, Diagnostic Test: Skin biopsy, Biological: Blood ProductParticipants with FMS without dysautonomia |
| Healthy volunteers | – | Other: Questionnaire and Physical Exam, Diagnostic Test: Nerve conduction studies, Diagnostic Test: Microneurography, Diagnostic Test: Quantitative Sensory Testing, Diagnostic Test: Skin biopsy, Biological: Blood ProductHealthy volunteers with no diagnosed autoimmune, chronic pain, or dysautonomia condition. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients diagnosed with PoTS (50% with comorbid FMS) 50 patients diagnosed with FMS without dysautonomia Up to 100 healthy volunteers
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamStandardised participant questionnaires assessing neurological symptoms, including pain (NPSI, DN4, BPI), fatigue (Fatigue Severity Scale), depression and anxiety (PHQ9 and GAD7) and autonomic dysfunction (Malmo PoTS Score and COMPASS-31). | Other | FMS, Healthy volunteers, PoTS with pain, PoTS without pain |
| Nerve conduction studiesMeasures how fast an electrical impulse moves through sensory and motor nerves. The test will be used to identify/rule out large fibre peripheral neuropathy. | Diagnostic test | FMS, Healthy volunteers, PoTS with pain, PoTS without pain |
| MicroneurographyElectrophysiological technique that can record action potentials from individual peripheral nerve axons in humans. The test will be used to identify/rule out small nerve fibre dysfunction. | Diagnostic test | FMS, Healthy volunteers, PoTS with pain, PoTS without pain |
| Quantitative Sensory TestingMeasures psychophysical sensory perception in response to different types of stimuli, such as thermal, mechanical, pressure and vibration. The test will be used to identify/rule out nerve fibre dysfunction, by generating a quantitative sensory profile of different sensory modalities. | Diagnostic test | FMS, Healthy volunteers, PoTS with pain, PoTS without pain |
| Skin biopsySafe and minimally invasive procedure to quantify intraepidermal nerve fibres density (IENFD). Reduced IENF density is associated with small fibre neuropathy. | Diagnostic test | FMS, Healthy volunteers, PoTS with pain, PoTS without pain |
| Blood ProductA blood sample of a maximum of 120ml will be collected from a superficial upper limb vein. Blood aliquots (50ml tubes) will then be centrifuged to separate serum from the peripheral blood cells. | Biological | FMS, Healthy volunteers, PoTS with pain, PoTS without pain |
Primary outcome
Evidence of immune-mediated pain mechanisms and autonomic dysfunction
Time frame: From enrollment until passive tranfer experiments are performed.
To determine whether IgG antibodies from PoTS participants (with or without FMS) induce pain-like behaviours and autonomic abnormalities in mice, following passive transfer.
4 secondary outcomes
Assessment of electrical activity recorded from nerve fibres in humans
Time frame: From enrollment until Visit 1.
Evidence of small fibre neuropathy (SFN)
Time frame: From enrollment until passive tranfer experiments are performed.
IgG binding to rodent neurons
Time frame: From enrollment until passive tranfer experiments are performed.
Correlation between participants symptoms and IgG effects in mice
Time frame: From enrollment until passive tranfer experiments are performed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Postural Orthostatic Tachycardia Syndrome (POTS) and Fibromyalgia (FM), run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Andersson (+447986420716, david.andersson@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of immune-mediated pain mechanisms and autonomic dysfunction (time frame: From enrollment until passive tranfer experiments are performed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.