The National Center for Testing Treatments in Chronic Spinal Cord and Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- International Standard Neurological Classification of Spinal Cord Injury
研究概览
简要总结
The NCTT is a prospective, multicenter, observational research network for subjects with chronic spinal cord and/or chronic traumatic brain injury.
详细描述
Current treatment for Spinal Cord Injury and Traumatic Brain Injury focuses on stabilizing the patient and preventing secondary injury with the aim of maximizing the best chance of recovery. Most patients will show varying amounts of recovery, but, when the injury is severe, that recovery is only partial. Enrollment in the NCTT will allow for classification and characterization of injury, function, co-morbidities, secondary issues/problems, research interests and will serve as a conduit for enrollment into interventional studies.
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
- •History of spinal cord injury and/or brain injury
- •Able to provide HIPAA authorization to share prior medical records/imaging
- •Age 18 and older.
排除标准
- •Life expectancy less than 6 months, vegetative state or co-existing disease or other characteristic that precludes appropriate diagnosis of spinal cord or brain injury.
- •Other condition 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 (e.g., ward of the state).
研究组 & 干预措施
Spinal Cord and Traumatic Brain Injury Subjects
Patients with a history of spinal cord and/or traumatic brain injury will provide data and samples so that they may be queried for interventional studies.
干预措施: Data and sample repository (Other)
Family Members and Healthy Volunteers
Healthy volunteer controls or family members may be enrolled for identification of genetic mutations.
干预措施: Data and sample repository (Other)
结局指标
主要结局
International Standard Neurological Classification of Spinal Cord Injury
时间窗: greater than 6 months post-injury
functional ability (sensory and motor) for spinal cord injury subjects
Disability Rating Scale
时间窗: greater than 6 months post-injury
functional outcome scale for brain injury subjects
次要结局
未报告次要终点
研究者
Georgene Hergenroeder
Study Director, PI, Associate Professor
The University of Texas Health Science Center, Houston