The Will Erwin Headache Research Center - Cluster Headache Study
キーワード
概要
説明
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.
日付
| 最終確認済み: | 10/31/2019 |
| 最初に提出された: | 09/14/2016 |
| 提出された推定登録数: | 09/18/2016 |
| 最初の投稿: | 09/21/2016 |
| 最終更新が送信されました: | 11/10/2019 |
| 最終更新日: | 11/12/2019 |
| 実際の研究開始日: | 04/30/2016 |
| 一次完了予定日: | 11/30/2035 |
| 研究完了予定日: | 11/30/2035 |
状態または病気
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 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. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| サンプリング方法 | Non-Probability Sample |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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 |
結果
主な結果の測定
1. HIT-6 scale [Through study completion, an average of 5 years]
2. Morningness-eveningness scale [Through study completion, an average of 5 years]
3. GAD-7 scale [Through study completion, an average of 5 years]
二次的な結果の測定
1. Genetic markers [Through study completion, an average of 5 years]
2. Molecular biomarkers [Through study completion, an average of 5 years]
