Imaging the Migraine Brain Pre- and Post-Erenumab: an MRI Study to Identify Functional and Structural Changes That Correlate With Patient Improvement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Resting State Functional Connectivity
研究概览
简要总结
Researchers are trying to determine if there is a difference between brain images of subjects that do respond to treatment with erenumab and subjects who do not respond to treatment with erenumab using Magnetic Resonance Imaging (MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erenumab
All participants receive erenumab 140mg by subcutaneous injection at baseline and again 4 weeks later.
干预措施: Erenumab (Drug)
结局指标
主要结局
Resting State Functional Connectivity
时间窗: 8 weeks
Brain MRI resting state functional connectivity measured as global efficiency percentage. An increase in global efficiency suggests an improvement in the ability of the brain regions to functionally communicate on a global scale. Efficiency relates to the network. In this case, the investigators defined the network to be the pain matrix. Increased efficiency would mean the connectivity within the matrix is increased and more efficient. This has not been attributed to a clinical outcome but is rather a characteristic of the network.
次要结局
- ROI-ROI Functional Connectivity of Dorsolateral Prefrontal Cortex Left With Hypothalamus Right(8 weeks)
- Erenumab Responders(8 weeks)
- ROI-ROI Functional Connectivity of Middle Temporal Left With Supramarginal Gyrus Right Regions of the Brain(8 weeks)
- ROI-ROI Functional Connectivity of Temporal Pole Right With Middle Occipital Right(8 weeks)
- ROI-ROI Functional Connectivity of Ventromedial Prefrontal Cortex Left With Pulvinar Right(8 weeks)
- Iron Accumulation in Anterior Cingulate Cortex Brain Region(8 weeks)
- Change in the Migraine Disability Assessment Questionnaire (MIDAS)(Baseline, 8 weeks)
- Iron Accumulation in Periaqueductal Gray Brain Region(8 weeks)
- ROI-ROI Functional Connectivity of Inferior Lateral Parietal Right With Middle Frontal Left(8 weeks)
- ROI-ROI Functional Connectivity of Inferior Lateral Parietal Right With Supramarginal Gyrus Right(8 weeks)
研究者
Todd J. Schwedt
Principal Investigator
Mayo Clinic