Observational study on cluster headaches and trigeminal neuralgia
The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia
This study is trying to learn more about cluster headaches and trigeminal neuralgia by gathering information from patients to help match them for future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT02910323 on ClinicalTrials.gov |
What this trial studies
The Will Erwin Headache Research Center is creating a national registry for patients with Cluster Headache and Trigeminal Neuralgia. This observational study will categorize participants based on various characteristics such as type and severity of their condition, associated symptoms, and psychological factors. Detailed evaluations will include genomic studies, medical history, imaging reports, and physical exams. The goal is to better understand these conditions and facilitate patient matching for future interventional clinical trials.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with trigeminal autonomic cephalalgias or trigeminal neuralgia as per the International Headache Classification.
Not a fit: Patients with a life expectancy of less than one year or those with conditions that hinder appropriate diagnosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cluster headaches and trigeminal neuralgia.
How similar studies have performed: Other studies have shown promise in understanding trigeminal autonomic cephalalgias, but this specific observational approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of a trigeminal autonomic cephalalgia according to the International Headache Classification including episodic cluster headache, chronic cluster headache, episodic paroxysmal hemicrania, chronic paroxysmal hemicrania, episodic short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT), chronic SUNCT, episodic short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (SUNA), chronic SUNA, and hemicrania continua. OR Diagnosis of a trigeminal neuralgia according to the International Headache Classification, including classical trigeminal neuralgia and symptomatic trigeminal neuralgia. * Able to provide HIPAA authorization to share prior medical records/imaging. Exclusion Criteria: * Life expectancy less than 1 year, co-existing disease or other characteristic that precludes appropriate diagnosis of a trigeminal autonomic cephalalgia or trigeminal neuralgia. * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * Inability or unwillingness of subject or legal guardian/representative to give informed consent. Inclusion Criteria for Healthy Volunteers: * Inclusion criteria is willingness to consent and be of age 18 and older
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Mark Burish, MD, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Rebecca Martinez, RN
- Email: nctt.wec@uth.tmc.edu
- Phone: 713-486-7771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.