WEC1: The Will Erwin Headache Research Center - Cluster Headache Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental group Patients with a history of Cluster Headaches and other TACs, or Trigeminal Neuralgia. |
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| Family/Healthy Controls Healthy volunteer controls and family members may be enrolled for identification of genetic mutations. |
Outcome Measures
Primary Outcome Measures
- HIT-6 scale [Through study completion, an average of 5 years]
- Morningness-eveningness scale [Through study completion, an average of 5 years]
- GAD-7 scale [Through study completion, an average of 5 years]
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Able to provide HIPAA authorization to share prior medical records/imaging.
Exclusion Criteria:
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Life expectancy less than 1 year, co-existing disease or other characteristic that precludes appropriate diagnosis of a trigeminal autonomic cephalalgia or trigeminal neuralgia.
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Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
Investigators
- Principal Investigator: Mark Burish, MD, PhD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
- HSC-MS-15-0780