Clinical trial NCT02910323: The Will Erwin Headache Research Center - Cluster Headache Study
Official title: The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cluster Headache
Cluster Headaches and Other Trigeminal Autonomic Cephalgias
Paroxysmal Hemicrania
SUNCT
Hemicrania Continua
Trigeminal Neuralgia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cluster Headache and Trigeminal Neuralgia patients, family members and healthy volunteers

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.

Eligibility 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

Primary outcomes:
measure: HIT-6 scale
timeFrame: Through study completion, an average of 5 years
measure: Morningness-eveningness scale
timeFrame: Through study completion, an average of 5 years
measure: GAD-7 scale
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
measure: Genetic markers
timeFrame: Through study completion, an average of 5 years
measure: Molecular biomarkers
timeFrame: Through study completion, an average of 5 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Mark Burish, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.