Pain Biomarker Study

Phase 1

Recruiting

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

• Registration Number: NCT03511846
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-4-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Diagnosis of one of the following: a. Diagnosis of a primary headache disorder<br> according to the International Headache Classification, including migraine with<br> aura, migraine without aura, chronic migraine, tension headache, cluster headache,<br> paroxysmal hemicrania, short-lasting unilateral neuralgiform headache attacks with<br> conjunctival injection and tearing (SUNCT), short-lasting unilateral neuralgiform<br> headache attacks with cranial autonomic symptoms (SUNA), and hemicrania continua; b.<br> Diagnosed by a pain medicine physician with lumbar radiculopathy (possibly including<br> neuropathic features, nerve impingement on MRI, or electromyography (EMG) report<br> suggestive of lumbar radiculopathy); or c. Healthy control subject with no history<br> of debilitating headaches or debilitating back pain / radiculopathy pain, and no<br> headaches or back pain within the previous 3 months.<br><br> - Able to provide HIPAA authorization to share prior medical records/imaging<br><br> - Age 18 and older<br><br>Exclusion Criteria:<br><br> - The following items exclude the subject from all portions of the study: a. Known<br> history of cardiovascular or neurovascular diseases. These diseases may include<br> carotid stenosis of >50%, vertebral stenosis, peripheral vascular disease, angina or<br> myocardial infarction, stroke, or vascular malformations; b. History of brain tumors<br> or epilepsy; c. Active pregnancy or lactation; d. Daily cigarette, tobacco or<br> nicotine use; e. Life expectancy less than 1 year, co-existing disease or other<br> characteristic that precludes appropriate diagnosis of headache or spine pain; f.<br> Active drug / alcohol use or dependence that, in the opinion of the investigator,<br> would interfere with adherence to study requirements; or g. Inability or<br> unwillingness of subject to give informed consent (e.g., ward of the state)<br><br> - The following items exclude the subject only from the capsaicin portion of the<br> study: a. Known allergy to capsaicin or hot peppers<br><br> - The following items exclude the subject only from the oxygen portion of the study:<br> a. Pulmonary or other non-headache diseases that require the use of supplemental<br> oxygen<br><br> - The following items exclude the subject only from the cold water irrigation (ice<br> water) portion of the study: a. Trauma, fractures, or congenital abnormalities of<br> the soft palate

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

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.;Activation of trigeminoautonomic reflex as assessed by tear fluid production

Secondary Outcome Measures

Name	Time	Method
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.;Activation of trigeminoautonomic reflex as assessed by saliva production;Activation of trigeminoautonomic reflex as assessed by nasal fluid production;Activation of trigeminoautonomic reflex as assessed by tactile threshold measurement with von Frey Filaments;Activation of trigeminoautonomic reflex as assessed by dermal blood flow