Pain Biomarker Study

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT03511846
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • Cluster Headache
  • Hemicrania Continua
  • Migraine
  • Paroxysmal Hemicrania
  • SUNCT
  • Short-Lasting Unilateral Neuralgiform Headache With Conjunctival Injection and Tearing
  • Trigeminal Autonomic Cephalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Oral capsaicin — DRUG
    Subjects will drink a solution with capsaicin
  • Topical capsaicin — DRUG
    Capsaicin cream will be applied to the skin of the forehead, cheek, or leg
  • Intranasal capsaicin — DRUG
    Capsaicin cream will be applied to the nostril
  • Cold Water Irrigation — OTHER
    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)
  • Medical Air — OTHER
    Subjects will be exposed to medical air
  • Low Flow Oxygen — DRUG
    Subjects will be exposed to oxygen gas between 1-9 L/min
  • High Flow Oxygen — DRUG
    Subjects will be exposed to oxygen gas between 10-25 L/min

Study Details

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.

Key Dates

Start date
Mar 21, 2018
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
371 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Oral capsaicin
  • Sham Comparator: Oral capsaicin and Medical Air
  • Experimental: Oral Capsaicin and Low Flow Oxygen
  • Experimental: Oral capsaicin and High Flow Oxygen
  • Experimental: Topical capsaicin
  • Sham Comparator: Topical capsaicin and Medical Air
  • Experimental: Topical capsaicin and Low Flow Oxygen
  • Experimental: Topical capsaicin and High Flow Oxygen
  • Experimental: Intranasal capsaicin
  • Sham Comparator: Intranasal capsaicin and Medical Air
  • Experimental: Intranasal capsaicin and Low Flow Oxygen
  • Experimental: Intranasal capsaicin and High Flow Oxygen
  • Experimental: Cold water irrigation
  • Sham Comparator: Cold water irrigation and Medical Air
  • Experimental: Cold water irrigation and Low Flow Oxygen
  • Experimental: Cold water irrigation and High Flow Oxygen

Primary Outcome Measure

Activation of trigeminoautonomic reflex as assessed by change in Calcitonin gene-related peptide (CGRP) levels from before stimulation to after stimulation. [ Time Frame: 10 minutes before pain stimulation and 10 minutes, 20 minutes, 30 minutes, 60 minutes, and 90 minutes after pain stimulation ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Migraine
By specialty
Neurology
By research site
The University of Texas Health Science Center at Houston· Houston, TX

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