Pain Biomarker Study
- Conditions
- MigraineTrigeminal Autonomic CephalgiaHemicrania ContinuaParoxysmal HemicraniaShort-Lasting Unilateral Neuralgiform Headache with Conjunctival Injection and TearingCluster HeadacheSUNCT
- Interventions
- Other: Cold Water IrrigationOther: Medical Air
- Registration Number
- NCT03511846
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 371
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral capsaicin Oral capsaicin - Oral capsaicin and Medical Air Oral capsaicin - Oral capsaicin and Medical Air Medical Air - Oral Capsaicin and Low Flow Oxygen Low Flow Oxygen - Oral capsaicin and High Flow Oxygen Oral capsaicin - Oral capsaicin and High Flow Oxygen High Flow Oxygen - Topical capsaicin Topical capsaicin - Topical capsaicin and Medical Air Topical capsaicin - Topical capsaicin and Medical Air Medical Air - Topical capsaicin and Low Flow Oxygen Low Flow Oxygen - Topical capsaicin and High Flow Oxygen Topical capsaicin - Topical capsaicin and High Flow Oxygen High Flow Oxygen - Intranasal capsaicin Intranasal capsaicin - Intranasal capsaicin and Medical Air Intranasal capsaicin - Intranasal capsaicin and Medical Air Medical Air - Intranasal capsaicin and Low Flow Oxygen Intranasal capsaicin - Intranasal capsaicin and Low Flow Oxygen Low Flow Oxygen - Intranasal capsaicin and High Flow Oxygen Intranasal capsaicin - Cold water irrigation Cold Water Irrigation - Cold water irrigation and Medical Air Cold Water Irrigation - Cold water irrigation and Medical Air Medical Air - Cold water irrigation and Low Flow Oxygen Cold Water Irrigation - Cold water irrigation and Low Flow Oxygen Low Flow Oxygen - Cold water irrigation and High Flow Oxygen Cold Water Irrigation - Cold water irrigation and High Flow Oxygen High Flow Oxygen - Intranasal capsaicin and High Flow Oxygen High Flow Oxygen - Topical capsaicin and Low Flow Oxygen Topical capsaicin - Oral Capsaicin and Low Flow Oxygen Oral capsaicin -
- Primary Outcome Measures
Name Time Method Activation of trigeminoautonomic reflex as assessed by change in Calcitonin gene-related peptide (CGRP) levels from before stimulation to after stimulation. 10 minutes before pain stimulation and 10 minutes, 20 minutes, 30 minutes, 60 minutes, and 90 minutes after pain stimulation Activation of trigeminoautonomic reflex as assessed by tear fluid production 90 minutes after pain stimulation The amount of tear fluid after each intervention will be measured via Schirmer strips
- Secondary Outcome Measures
Name Time Method Activation of trigeminoautonomic reflex as assessed by dermal blood flow 90 minutes after pain stimulation Activation of trigeminoautonomic reflex as assessed by change in pituitary adenylate cyclase activating polypeptide-38 (PACAP-38) levels levels from before stimulation to after stimulation. 10 minutes before pain stimulation and 10 minutes, 20 minutes, 30 minutes, 60 minutes, and 90 minutes after pain stimulation Activation of trigeminoautonomic reflex as assessed by saliva production 90 minutes after pain stimulation Activation of trigeminoautonomic reflex as assessed by nasal fluid production 90 minutes after pain stimulation Activation of trigeminoautonomic reflex as assessed by tactile threshold measurement with von Frey Filaments 90 minutes after pain stimulation
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States