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Biomarkers for Pain in Spinal Cord Injury (SCI) Patients - NCT00913471-77030(Clinical Trial 296556)



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City:  Houston
State:  
TX
Zip Code: 77030
Conditions: Traumatic Spinal Cord Injury - Neuropathic Pain
Purpose: 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.
Study summary:
Criteria: A. Chronic Patients Inclusion: 1. Two or more years post traumatic SCI with deficit Exclusion: 1. < 18 years of age 2. Evidence of brain injury on computed tomography (CT) (SCI patients need to be able to comply with completing the pain survey) 3. Other medical condition that accounts for chronic pain (i.e. diabetic neuropathy, renal insufficiency, multiple sclerosis, HIV associated neuropathy, alcohol-related neuropathy) 4. Temperature > 100.5°C 5. History of infection within the last 30 days (i.e. UTI, URI, pressure sore) 6. History of Pulmonary Embolus (PE) or deep vein thrombosis (DVT) 7. Inability to obtain informed consent 8. Psychiatric problems (patients need to be able to complete the pain survey) 9. Diagnosis or treatment of cancer in the last 5 years B. Longitudinal, Prospective Cohort Patients: Inclusion: 1. Initial traumatic SCI with deficit Exclusion: Same as listed above C. Healthy Volunteers Healthy volunteers include gender, age and race matched volunteers able to provide informed consent who have, 1. No significant medical history (pain free) 2. No recent infections 3. Take no medications 4. Fever free 5. Greater than 18 years old
Study is available at: Memorial Hermann Hospital
Houston, TX 77030
United States

Primary Contact:
Georgene W Hergenroeder, MHA, RN
Email: Georgene.W.Hergenroeder@uth.tmc.edu
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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