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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)
Masking Description
In the oxygen portion of the study, subjects and the outcomes assessors will be told that they will be receiving either medical air or oxygen.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Oral capsaicin
  • Drug: Oral capsaicin
    Subjects will drink a solution with capsaicin
Sham Comparator
Oral capsaicin and Medical Air
  • Drug: Oral capsaicin
    Subjects will drink a solution with capsaicin
  • Other: Medical Air
    Subjects will be exposed to medical air
Experimental
Oral Capsaicin and Low Flow Oxygen
  • Drug: Oral capsaicin
    Subjects will drink a solution with capsaicin
  • Drug: Low Flow Oxygen
    Subjects will be exposed to oxygen gas between 1-9 L/min
Experimental
Oral capsaicin and High Flow Oxygen
  • Drug: Oral capsaicin
    Subjects will drink a solution with capsaicin
  • Drug: High Flow Oxygen
    Subjects will be exposed to oxygen gas between 10-25 L/min
Experimental
Topical capsaicin
  • Drug: Topical capsaicin
    Capsaicin cream will be applied to the skin of the forehead, cheek, or leg
Sham Comparator
Topical capsaicin and Medical Air
  • Drug: Topical capsaicin
    Capsaicin cream will be applied to the skin of the forehead, cheek, or leg
  • Other: Medical Air
    Subjects will be exposed to medical air
Experimental
Topical capsaicin and Low Flow Oxygen
  • Drug: Topical capsaicin
    Capsaicin cream will be applied to the skin of the forehead, cheek, or leg
  • Drug: Low Flow Oxygen
    Subjects will be exposed to oxygen gas between 1-9 L/min
Experimental
Topical capsaicin and High Flow Oxygen
  • Drug: Topical capsaicin
    Capsaicin cream will be applied to the skin of the forehead, cheek, or leg
  • Drug: High Flow Oxygen
    Subjects will be exposed to oxygen gas between 10-25 L/min
Experimental
Intranasal capsaicin
  • Drug: Intranasal capsaicin
    Capsaicin cream will be applied to the nostril
Sham Comparator
Intranasal capsaicin and Medical Air
  • Drug: Intranasal capsaicin
    Capsaicin cream will be applied to the nostril
  • Other: Medical Air
    Subjects will be exposed to medical air
Experimental
Intranasal capsaicin and Low Flow Oxygen
  • Drug: Intranasal capsaicin
    Capsaicin cream will be applied to the nostril
  • Drug: Low Flow Oxygen
    Subjects will be exposed to oxygen gas between 1-9 L/min
Experimental
Intranasal capsaicin and High Flow Oxygen
  • Drug: Intranasal capsaicin
    Capsaicin cream will be applied to the nostril
  • Drug: High Flow Oxygen
    Subjects will be exposed to oxygen gas between 10-25 L/min
Experimental
Cold water irrigation
  • Other: Cold Water Irrigation
    Subjects will be asked to drink up to 2000 ml of cold water or ice water (temperature 0-10 degrees Celsius) as fast as possible, either continuously or intermittently (i.e. 200-800 ml at a time)
Sham Comparator
Cold water irrigation and Medical Air
  • Other: Cold Water Irrigation
    Subjects will be asked to drink up to 2000 ml of cold water or ice water (temperature 0-10 degrees Celsius) as fast as possible, either continuously or intermittently (i.e. 200-800 ml at a time)
  • Other: Medical Air
    Subjects will be exposed to medical air
Experimental
Cold water irrigation and Low Flow Oxygen
  • Other: Cold Water Irrigation
    Subjects will be asked to drink up to 2000 ml of cold water or ice water (temperature 0-10 degrees Celsius) as fast as possible, either continuously or intermittently (i.e. 200-800 ml at a time)
  • Drug: Low Flow Oxygen
    Subjects will be exposed to oxygen gas between 1-9 L/min
Experimental
Cold water irrigation and High Flow Oxygen
  • Other: Cold Water Irrigation
    Subjects will be asked to drink up to 2000 ml of cold water or ice water (temperature 0-10 degrees Celsius) as fast as possible, either continuously or intermittently (i.e. 200-800 ml at a time)
  • Drug: High Flow Oxygen
    Subjects will be exposed to oxygen gas between 10-25 L/min

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Rebecca Martinez, RN
713-486-7771
nctt.wec@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Rebecca Martinez, RN
713-704-7771
NCTT.WEC@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.