Spontaneous Intracranial Hypotension Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in Headache Impact Test (HIT-6)
研究概览
简要总结
The purpose of this research is to determine the efficacy of paraspinal vein embolization for treatment of digital subtraction myelography (DSM) or CT myelography (CTM) confirmed cerebrospinal fluid (CSF)-venous fistulas so that researchers can inform the development and design of future clinical trials of this technique.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Study subjects will be patients who meet the International Classification of Headache - Disorders 3rd Edition (ICHD-3) criteria for a diagnosis of SIH or the Schievink criteria with imaging confirmed CSF-venous fistulas on DSM or CTM.
- •Availability of a clinically prescribed contrast enhanced MRI positive for SIH.
- •Negative urine or serum pregnancy test at time of study consent and three-months.
排除标准
- •Patients who have a contraindication or inability to undergo the procedure (i.e., severe contrast allergy).
- •Inability to provide informed consent.
- •Expected inability to complete the follow-up assessment.
- •Current pregnancy or breast-feeding during study enrollment (from consent to study conclusion approximately 90-days).
研究组 & 干预措施
Group 1 Baseline, 3 months, 1 year, 1.5 years, and 2 years Questionnaires
170 participants with BERN imaging score with completion of baseline, 3 months, 1 year, 1.5 years, and 2 years questionnaires being : headache impact test (HIT-6), migraine disability assessment test (MIDAS), pain numerical rating scale (NRS), and spontaneous intracranial hypotension symptom severity scale (SIHSS).
Each participant will keep a daily headache diary for 90 days.
干预措施: Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula (Procedure)
Group 2 Baseline, 7 days and 3 month, 1 year, 1.5 years, and 2 years Questionnaires
30 participants with BERN imaging score with completion of baseline, 7 days, 3 months, 1 year, 1.5 years, and 2 years questionnaires being : headache impact test (HIT-6), migraine disability assessment test (MIDAS), pain numerical rating scale (NRS), and spontaneous intracranial hypotension symptom severity scale (SIHSS).
Each participant will keep a daily headache diary for 90 days.
干预措施: Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula (Procedure)
结局指标
主要结局
Change in Headache Impact Test (HIT-6)
时间窗: Baseline, 3 months, 1 year, 1.5 years, 2 years
HIT-6 is a 6-item validated headache assessment tool designed to provide a global measure of headache impact in social functioning, role functioning, vitality, cognition, psychological distress, and severity of headache. Total score ranges 36-78: 36-49: little or no impact; 50-55 some impact; 56-59 substantial impact; \>60 severe impact.
Change in Bern SIH MRI Score
时间窗: Baseline, 3 months, 1 year, 1.5 years, 2 years
The Bern SIH MRI score is a validated 9-point score assessing the severity of imaging finding suggestive of SIH. Calculated by adding the individual components for a score range of 0-9. Classified as low, intermediate, or high probability of having a CSF leak based on total Bern SIH score of 2 points or fewer (low), 3-4 points (intermediate), or 5 points or more (high).
次要结局
- Change in Pain Numerical Rating Scale (NRS)(Baseline, 3 months, 1 year, 1.5 years, 2 years)
- Change in Migraine Disability Assessment (MIDAS)(Baseline, 3 months, 1 year, 1.5 years, 2 years)
研究者
Waleed Brinjikji
Principal Investigator
Mayo Clinic