Biomarkers for Pain in Spinal Cord Injury (SCI) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To identify candidate biomarkers for pain in the chronic SCI samples.
研究概览
简要总结
The investigators propose to compare plasma protein profiles for SCI patients with/without chronic neuropathic pain in order identify biomarker(s) that are associated with this medical condition. Secondly, the investigators propose to identify a temporal relationship to initial SCI at which these biomarkers manifest.
Our working hypothesis is that sustained alterations in specific inflammatory molecules are associated with chronic neuropathic pain following SCI, and that their plasma levels can serve as biomarkers to identify patients at risk for the development of neuropathic pain.
Additionally the investigators are collecting skin tissue biopsy samples from patients following acute and chronic spinal cord injury to create vector-free human iPS cells from fibroblasts by direct delivery of reprogramming proteins.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A. Chronic Patients
- •1. Two or more years post traumatic SCI with deficit
排除标准
- •< 18 years of age
- •Evidence of brain injury on computed tomography (CT) (SCI patients need to be able to comply with completing the pain survey)
- •Other medical condition that accounts for chronic pain (i.e. diabetic neuropathy, renal insufficiency, multiple sclerosis, HIV associated neuropathy, alcohol-related neuropathy)
- •Temperature > 100.5°C
- •History of infection within the last 30 days (i.e. UTI, URI, pressure sore)
- •History of Pulmonary Embolus (PE) or deep vein thrombosis (DVT)
- •Inability to obtain informed consent
- •Psychiatric problems (patients need to be able to complete the pain survey)
- •Diagnosis or treatment of cancer in the last 5 years
- •B. Longitudinal, Prospective Cohort Patients:
- •1. Initial traumatic SCI with deficit
- •Same as listed above C. Healthy Volunteers Healthy volunteers include gender, age and race matched volunteers able to provide informed consent who have,
- •No significant medical history (pain free)
- •No recent infections
- •Take no medications
- •Greater than 18 years old
研究组 & 干预措施
Acute-Longitudinal SCI
干预措施: blood samples (Other)
Chronic SCI
干预措施: blood samples (Other)
Healthy volunteers
干预措施: blood samples (Other)
结局指标
主要结局
To identify candidate biomarkers for pain in the chronic SCI samples.
时间窗: two or more years post injury
次要结局
- To identify the temporal relationship of the development of pain and the manifestation of the biomarkers identified(two or more years post injury)
研究者
Georgene Hergenroeder
Associate Professor, Neurosurgery
The University of Texas Health Science Center, Houston