The Will Erwin Headache Research Center - Cluster Headache Study

Recruiting

• Conditions: Cluster Headaches and Other Trigeminal Autonomic Cephalgias; Paroxysmal Hemicrania; Hemicrania Continua; SUNCT; Trigeminal Neuralgia; Cluster Headache

• Registration Number: NCT02910323
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia is a prospective, multicenter, observational research network for subjects with Cluster Headache and/or Trigeminal Neuralgia.

Detailed Description

The Will Erwin Headache Research Center will assemble a national registry of Cluster Headache patients and will sub-categorize and organize this cohort based on individuating characteristics including but not limited to type and severity of condition, associated symptoms, and medical/psychological issues (e.g., depression, disability, sleep). Detailed evaluations and classification will be completed for each enrolled subject. This will encompass genomic and epigenomic studies, past medical history, imaging reports, and specific physical exam results for each patient. It will also enable the study investigators to match patients with suitable interventional clinical trials.

Similar diseases, such as other paroxysmal hemicrania, SUNCT, SUNA, hemicrania continua, and trigeminal neuralgia may also be investigated.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2035-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morningness-eveningness scale	Through study completion, an average of 5 years
GAD-7 scale	Through study completion, an average of 5 years
HIT-6 scale	Through study completion, an average of 5 years

Secondary Outcome Measures

Name	Time	Method
Genetic markers	Through study completion, an average of 5 years	Results of GWAS or other genetic tests
Molecular biomarkers	Through study completion, an average of 5 years	Results of ELISAs for autonomic, hypothalamic, and pain signalling molecules

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States