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The Will Erwin Headache Research Center - Cluster Headache Study (WEC1)

This study is currently recruiting participants.
Verified October 2017 by Mark J Burish, The University of Texas Health Science Center, Houston
Sponsor:
ClinicalTrials.gov Identifier:
NCT02910323
First Posted: September 22, 2016
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark J Burish, The University of Texas Health Science Center, Houston
  Purpose
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
Cluster Headache Cluster Headaches and Other Trigeminal Autonomic Cephalgias Paroxysmal Hemicrania SUNCT Hemicrania Continua Trigeminal Neuralgia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia

Resource links provided by NLM:


Further study details as provided by Mark J Burish, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Blood, urine, saliva, skin cells, other

Estimated Enrollment: 1500
Study Start Date: May 2016
Estimated Study Completion Date: December 2035
Estimated Primary Completion Date: December 2035 (Final data collection date for primary outcome measure)
Groups/Cohorts
Experimental group
Patients with a history of Cluster Headaches and other TACs, or Trigeminal Neuralgia.
Family/Healthy Controls
Healthy volunteer controls and family members may be enrolled for identification of genetic mutations.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cluster Headache and Trigeminal Neuralgia patients, family members and healthy volunteers
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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Elena Viverette, RN 713-704-6900 nctt.wec@uth.tmc.edu
Contact: Mark J Burish, MD, PhD 713-704-6900

Locations
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Elena Viverette, RN    713-704-6900    nctt.wec@uth.tmc.edu   
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
  More Information

Publications:
Responsible Party: Mark J Burish, Assistant Professor, Neurosurgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02910323     History of Changes
Other Study ID Numbers: HSC-MS-15-0780
First Submitted: September 15, 2016
First Posted: September 22, 2016
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Headache
Neuralgia
Cluster Headache
Trigeminal Neuralgia
Anencephaly
Paroxysmal Hemicrania
Trigeminal Autonomic Cephalalgias
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular 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