The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Morningness-eveningness scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Family/Healthy Controls
Healthy volunteer controls and family members may be enrolled for identification of genetic mutations.
Experimental group
Patients with a history of Cluster Headaches and other TACs, or Trigeminal Neuralgia.
结局指标
主要结局
Morningness-eveningness scale
时间窗: Through study completion, an average of 5 years
GAD-7 scale
时间窗: Through study completion, an average of 5 years
HIT-6 scale
时间窗: Through study completion, an average of 5 years
次要结局
- Genetic markers(Through study completion, an average of 5 years)
- Molecular biomarkers(Through study completion, an average of 5 years)
研究者
Mark J Burish
Assistant Professor, Neurosurgery
The University of Texas Health Science Center, Houston