Imaging Myelin Injury in Amyotrophic Lateral Sclerosis (ALS)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- MRI Changes in ALS Patients Vs Healthy Controls
研究概览
简要总结
This is a pilot study to identify the degree of grey and white matter involvement in patients with Amyotrophic Lateral Sclerosis (ALS) utilizing non-invasive techniques. The imaging to be utilized will be the 7 Tesla (7T) magnetic resonance imaging (MRI) of the brain. These results will be correlated to the ALS Functional Rating Scale - Revised (ALSFRS-R) score to assess if any changes in MRI can be predictive in the disability of the ALS patients at baseline and at 6 month intervals. The participants will be asked to return every 6 months for a neurological examination, ALSFRS-R assessment, measurement of the vital capacity and MRI as outlined above to monitor progression of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females who are 18 - 80 years old.
- •The participants will meet the standard diagnostic criteria for possible or probable ALS (based on El Escorial criteria). They will have been diagnosed by a Johns Hopkins Neurologist.
- •Healthy controls will be recruited by their interest in assisting the ALS population.
排除标准
- •Forced vital capacity less than 60 % of predicted value.
- •Documented orthopnea on ALSFRS-R or otherwise unable to lie flat in an MRI scanner for the duration of the study.
- •Presence of pacemakers, aneurysm clips, shrapnel or otherwise disallowed implanted metallic devices for obtaining an MRI scan.
- •Pregnant or lactating females
- •Glomerular filtration rate (GFR) less than 60
- •History of: encephalitis, extensive white matter disease, intracranial hemorrhage, cerebral palsy, allergy to dye and/or IV drug abuse.
结局指标
主要结局
MRI Changes in ALS Patients Vs Healthy Controls
时间窗: 2 years
Voxel Based Morphometry will be utilized to look for any changes in the MRI results comparing ALS subjects to healthy volunteers.
次要结局
- MRI Changes in ALS Patients(2 years)
研究者
Dr. Jeffrey Rothstein
Professor of Neurology
Johns Hopkins University