Pain Biomarker Study

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Apr 26, 2018

Keywords

ClinConnect Summary

The Pain Biomarker Study is a clinical trial designed to explore the biological and physical signs associated with different types of headaches, including migraines and cluster headaches. Researchers want to understand how these headaches work and how certain treatments might be more effective for specific patients. The study has three main parts: First, participants will apply a cream containing capsaicin (the ingredient found in hot chili peppers) to see how it affects headache-related molecules. Second, they’ll investigate whether breathing in oxygen can reduce eye watering in cluster headache patients. Lastly, the study will look at how drinking ice water can trigger headaches, which may help researchers learn more about headache triggers in general.

To participate, individuals must be at least 18 years old and have a diagnosed primary headache disorder, like migraine or tension headaches. Healthy individuals without a history of debilitating headaches or back pain may also be eligible. Participants will engage in various non-invasive tests and will need to share some medical history for the study. It’s important to note that certain health conditions, such as heart diseases or active pregnancy, may prevent someone from joining the trial. Overall, this study aims to improve our understanding of headaches and potentially lead to better treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of one of the following: a. Diagnosis of a primary headache disorder according to the International Headache Classification, including migraine with aura, migraine without aura, chronic migraine, tension headache, cluster headache, paroxysmal hemicrania, short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT), short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (SUNA), and hemicrania continua; b. Diagnosed by a pain medicine physician with lumbar radiculopathy (possibly including neuropathic features, nerve impingement on MRI, or electromyography (EMG) report suggestive of lumbar radiculopathy); or c. Healthy control subject with no history of debilitating headaches or debilitating back pain / radiculopathy pain, and no headaches or back pain within the previous 3 months.
• • Able to provide HIPAA authorization to share prior medical records/imaging
• • Age 18 and older
• Exclusion Criteria:
• • The following items exclude the subject from all portions of the study: a. Known history of cardiovascular or neurovascular diseases. These diseases may include carotid stenosis of \>50%, vertebral stenosis, peripheral vascular disease, angina or myocardial infarction, stroke, or vascular malformations; b. History of brain tumors or epilepsy; c. Active pregnancy or lactation; d. Daily cigarette, tobacco or nicotine use; e. Life expectancy less than 1 year, co-existing disease or other characteristic that precludes appropriate diagnosis of headache or spine pain; f. Active drug / alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements; or g. Inability or unwillingness of subject to give informed consent (e.g., ward of the state)
• • The following items exclude the subject only from the capsaicin portion of the study: a. Known allergy to capsaicin or hot peppers
• • The following items exclude the subject only from the oxygen portion of the study: a. Pulmonary or other non-headache diseases that require the use of supplemental oxygen
• • The following items exclude the subject only from the cold water irrigation (ice water) portion of the study: a. Trauma, fractures, or congenital abnormalities of the soft palate