Pain Biomarker Study
Pain Biomarker Study
This study investigates molecular and physical biomarkers of headaches in order to better
 understand mechanisms of these diseases.

 There are 3 main parts:

 1. Use of capsaicin (active ingredient in hot chili peppers) to trigger release of
 calcitonin gene related peptide - the hypothesis is that this will be different in
 headache subjects compared to controls (and if so might be used to predict how these
 patients will respond to certain medications that modulate calcitonin gene-related
 peptide). Subjects will be given capsaicin as a cream applied to the forehead or the
 inner nostril, or a hot sauce that is ingested.

 2. Use of capsaicin to trigger eye watering - the hypothesis is that oxygen gas will slow
 down the amount of eye watering. Cluster headache patients respond very powerfully to
 oxygen gas but to very little else. The mechanism for oxygen is unknown but in rodents
 there is data that it works on the parasympathetic / lacrimal gland system. This study
 translates rodent data into humans in a non-invasive way to confirm the mechanism of
 this very effective treatment.

 3. Use of ice water to trigger headaches - brain freeze causes a very short-lived but
 intense headache that may cause similar biomarker release as other headache disorders.
 This may be a useful human model for other headache disorders.
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