The Will Erwin Headache Research Center - Cluster Headache Study (WEC1)
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| ClinicalTrials.gov Identifier: NCT02910323 |
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Recruitment Status :
Recruiting
First Posted : September 22, 2016
Last Update Posted : May 25, 2022
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| Condition or disease |
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| Cluster Headache Cluster Headaches and Other Trigeminal Autonomic Cephalgias Paroxysmal Hemicrania SUNCT Hemicrania Continua Trigeminal Neuralgia |
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 Type : | Observational |
| Estimated Enrollment : | 1500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia |
| Study Start Date : | May 2016 |
| Estimated Primary Completion Date : | December 2035 |
| Estimated Study Completion Date : | December 2035 |
| Group/Cohort |
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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.
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- HIT-6 scale [ Time Frame: Through study completion, an average of 5 years ]
- Morningness-eveningness scale [ Time Frame: Through study completion, an average of 5 years ]
- GAD-7 scale [ Time Frame: Through study completion, an average of 5 years ]
- Genetic markers [ Time Frame: Through study completion, an average of 5 years ]Results of GWAS or other genetic tests
- Molecular biomarkers [ Time Frame: Through study completion, an average of 5 years ]Results of ELISAs for autonomic, hypothalamic, and pain signalling molecules
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910323
| Contact: Rebecca Martinez, RN | 713-486-7771 | nctt.wec@uth.tmc.edu | |
| Contact: Mark J Burish, MD, PhD | 713-486-7771 |
| United States, Texas | |
| The University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Rebecca Martinez, RN 713-486-7771 nctt.wec@uth.tmc.edu | |
| Principal Investigator: | Mark Burish, MD, PhD | The University of Texas Health Science Center, Houston |
| Responsible Party: | Mark J Burish, Assistant Professor, Neurosurgery, The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT02910323 |
| Other Study ID Numbers: |
HSC-MS-15-0780 |
| First Posted: | September 22, 2016 Key Record Dates |
| Last Update Posted: | May 25, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
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Trigeminal Neuralgia Neuralgia Cluster Headache Anencephaly Trigeminal Autonomic Cephalalgias Paroxysmal Hemicrania Headache Pain Neurologic Manifestations Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Headache Disorders, Primary |
Headache Disorders Brain Diseases Central Nervous System Diseases Trigeminal Nerve Diseases Facial Neuralgia Facial Nerve Diseases Mouth Diseases Stomatognathic Diseases Cranial Nerve Diseases Neural Tube Defects Nervous System Malformations Abnormalities, Severe Teratoid Congenital Abnormalities |