Painful Channelopathies Study (NCT02696746) | Clinical Trial Compass
UnknownNot Applicable
Painful Channelopathies Study
United Kingdom100 participantsStarted 2012-02
Plain-language summary
To understand the pathophysiological basis of heritable pain syndromes. This will consist of a number of components:
* Determine the genetic basis for heritable pain syndromes.
* Investigate the pain symptoms, psychological co-morbidity and quality of life in patients with heritable pain syndromes.
* Use quantitative sensory testing to investigate abnormalities in sensory processing.
* Use imaging modalities to investigate the neural correlates of pain perception in heritable channelopathies.
* In select patients to perform skin biopsy to determine if there has been any damage to C-fibres.
* To perform skin biopsy in order to culture fibroblasts and neural crest stem cells for future studies into the molecular basis of altered pain perception.
* To use neurophysiological tests, the axon reflex, and conditioning challenges to determine how peripheral nerves, in heritable channelopathies and unusual pain syndromes, have been altered.
* Microneurographic recordings for directly detecting the function of pain fibres in peripheral nerves. Knowledge gained from the study will be used to aid the further development of genetic testing and specific pain questionnaires for the diagnosis of heritable pain syndromes secondary to channelopathies.
* Ultimately better knowledge of underlying pathophysiology in these heritable pain conditions may inform the development of novel treatments.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are ≥16 years of age who have a set of symptoms that resemble those seen on Paroxysmal Extreme Pain Disorder, Familial Episodic Pain Syndrome or Erythromelalgia.
* Patients already with the diagnosis of Paroxysmal Extreme Pain Disorder or Familial Episodic Pain Syndrome or Erythromelalgia.
* Patients with reduced pain sensibility.
* First degree relatives of patients who meet diagnostic criteria for Paroxysmal Extreme Pain Disorder, Familial Episodic Pain Syndrome, Erythromelalgia or inability to experience pain.
* Patients who do not fulfill any of the exclusion criteria.
Exclusion Criteria:
* Pregnant subjects.
* Subjects with insufficient command of English to obtain consent from or to complete the study questionnaires.
* Subjects with insufficient mental capacity to obtain consent from or to complete the study questionnaires.
* Subjects with concurrent severe psychological or psychiatric disorders, specially those patients with severe claustrophobia.
* Patients with moderate to severe pain arising as a consequence of other disorders causing pain but that are not associated with those mentioned before as channelopathies.
* Patients with central nervous system diseased that may complicate the somatosensory testing.
* The skin biopsy procedure, will not be conducted on those patients with contraindications to do so i.e. anticoagulation therapy, skin infections, etc; that might result in adverse outcomes (if the subject decides to decline…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.