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The Will Erwin Headache Research Center - Cluster Headache Study

NCT ID: NCT02910323

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2035-12-31

Brief Summary

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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

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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.

Conditions

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Cluster Headache Cluster Headaches and Other Trigeminal Autonomic Cephalgias Paroxysmal Hemicrania SUNCT Hemicrania Continua Trigeminal Neuralgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group

Patients with a history of Cluster Headaches and other TACs, or Trigeminal Neuralgia.

No interventions assigned to this group

Family/Healthy Controls

Healthy volunteer controls and family members may be enrolled for identification of genetic mutations.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Mark J Burish

Assistant Professor, Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Burish, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rebecca Martinez, RN

Role: CONTACT

Phone: 713-486-7771

Email: [email protected]

Mark J Burish, MD, PhD

Role: CONTACT

Phone: 713-486-7771

Facility Contacts

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Rebecca Martinez, RN

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 23771276 (View on PubMed)

Other Identifiers

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HSC-MS-15-0780

Identifier Type: -

Identifier Source: org_study_id