The Will Erwin Headache Research Center - Cluster Headache Study

NCT02910323 | Recruiting

• 1 other identifier: HSC-MS-15-0780
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Genetic markers

  Through study completion, an average of 5 years

• Molecular biomarkers

  Through study completion, an average of 5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cluster Headache and Trigeminal Neuralgia patients, family members and healthy volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 23771276 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, saliva, skin cells, other

MeSH Terms

Conditions

Cluster Headache; Paroxysmal Hemicrania; Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases

Study Officials

• Mark Burish, MD, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Martinez, RN

CONTACT

713-486-7771; nctt.wec@uth.tmc.edu

Mark J Burish, MD, PhD

CONTACT

713-486-7771

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Neurosurgery

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: September 22, 2016
• Study Start: July 12, 2016
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)