Pain Biomarker Study (PBS)
Migraine, Cluster Headache, Trigeminal Autonomic Cephalgia
About this trial
This is an interventional basic science trial for Migraine focused on measuring Brain Freeze, Capsaicin
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Experimental
Sham Comparator
Experimental
Experimental
Experimental
Sham Comparator
Experimental
Experimental
Experimental
Sham Comparator
Experimental
Experimental
Experimental
Sham Comparator
Experimental
Experimental
Oral capsaicin
Oral capsaicin and Medical Air
Oral Capsaicin and Low Flow Oxygen
Oral capsaicin and High Flow Oxygen
Topical capsaicin
Topical capsaicin and Medical Air
Topical capsaicin and Low Flow Oxygen
Topical capsaicin and High Flow Oxygen
Intranasal capsaicin
Intranasal capsaicin and Medical Air
Intranasal capsaicin and Low Flow Oxygen
Intranasal capsaicin and High Flow Oxygen
Cold water irrigation
Cold water irrigation and Medical Air
Cold water irrigation and Low Flow Oxygen
Cold water irrigation and High Flow Oxygen