NCT06132529已完成不适用
Biomarker Signature to Predict the Persistence of Post-traumatic Headache
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Prediction of post-traumatic headache recovery
研究概览
简要总结
The purpose of this research study is to develop a model to help distinguish patients at high-risk for developing persistent post-traumatic headache from patients who experience headache recovery. Researchers will do this by comparing the brain images, clinical data, and speech of healthy controls to people who have been diagnosed with post-traumatic headache.
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
- •Post-traumatic headache (PTH) and persistent post-traumatic headache (PPTH) will be diagnosed using the ICHD-3 diagnostic criteria for PTH attributed to mild traumatic brain injury (concussion).
- •For patients with PTH, only patients with new onset of PTH without history of PPTH will be included in the study.
- •A personal history of prior concussion and history of migraine are allowed according to ICHD-III diagnostic criteria.
- •Tension-type headaches on three or fewer days per month is allowed for healthy control subjects.
排除标准
- •History of moderate or severe traumatic brain injurie (TBI).
- •Prior history of gross anatomical change on imaging.
- •Contraindication to MRI, including but not limited to severe claustrophobia and/or presence of ferrous materials in the body.
- •Women who are pregnant, or believe that they might be pregnant. Although there are no known contraindications or risks associated with pregnancy and MRI, we will exclude pregnant women or women who believe that there might be a chance that they are pregnant.
- •History of concussion or more severe TBI.
- •History of migraine or other headaches.
- •The diagnosis for PTH and PPTH will be verified by Dr. Schwedt (co-investigator) a board-certified physician in Neurology and Headache Medicine. Presence of concussion will be verified using the Ohio State University TBI Identification Method, a standardized questionnaire assessing the lifetime history of TBI for an individual.
结局指标
主要结局
Prediction of post-traumatic headache recovery
时间窗: 6 years
Using questionnaires and fMRI
次要结局
未报告次要终点
研究者
Catherine (Cat) Chong
Principal Investigator
Mayo Clinic
研究点 (2)
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