Pain Biomarker Study

Last updated: January 10, 2025
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Enrolling

Phase

1

Condition

Pain (Pediatric)

Oral Facial Pain

Pain

Treatment

Medical Air

High Flow Oxygen

Topical capsaicin

Clinical Study ID

NCT03511846
HSC-MS-17-0763
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of one of the following: a. Diagnosis of a primary headache disorderaccording to the International Headache Classification, including migraine withaura, migraine without aura, chronic migraine, tension headache, cluster headache,paroxysmal hemicrania, short-lasting unilateral neuralgiform headache attacks withconjunctival injection and tearing (SUNCT), short-lasting unilateral neuralgiformheadache attacks with cranial autonomic symptoms (SUNA), and hemicrania continua; b.Diagnosed by a pain medicine physician with lumbar radiculopathy (possibly includingneuropathic features, nerve impingement on MRI, or electromyography (EMG) reportsuggestive of lumbar radiculopathy); or c. Healthy control subject with no historyof debilitating headaches or debilitating back pain / radiculopathy pain, and noheadaches or back pain within the previous 3 months.

  • Able to provide HIPAA authorization to share prior medical records/imaging

  • Age 18 and older

Exclusion

Exclusion Criteria:

  • The following items exclude the subject from all portions of the study: a. Knownhistory of cardiovascular or neurovascular diseases. These diseases may includecarotid stenosis of >50%, vertebral stenosis, peripheral vascular disease, angina ormyocardial infarction, stroke, or vascular malformations; b. History of brain tumorsor epilepsy; c. Active pregnancy or lactation; d. Daily cigarette, tobacco ornicotine use; e. Life expectancy less than 1 year, co-existing disease or othercharacteristic 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 orunwillingness of subject to give informed consent (e.g., ward of the state)

  • The following items exclude the subject only from the capsaicin portion of thestudy: 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 supplementaloxygen

  • The following items exclude the subject only from the cold water irrigation (icewater) portion of the study: a. Trauma, fractures, or congenital abnormalities ofthe soft palate

Study Design

Total Participants: 371
Treatment Group(s): 7
Primary Treatment: Medical Air
Phase: 1
Study Start date:
March 21, 2018
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

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