Biomarkers for Pain in Spinal Cord Injury (SCI) Patients

Study Overview
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Brief Summary
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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.

Official Title
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Biomarkers for Pain in Spinal Cord Injury (SCI) Patients

Conditions
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Traumatic Spinal Cord Injury, Neuropathic Pain

Intervention / Treatment
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* Other: blood samples


Participation Criteria
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Eligibility Criteria
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A. Chronic Patients Inclusion: 1. Two or more years post traumatic SCI with deficit Exclusion: < 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: 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, No significant medical history (pain free) No recent infections Take no medications Fever free Greater than 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute-Longitudinal SCI<br> | Other: blood samples<br>* Chronic patients - a one time blood sample (12 mL) and questionnaire; 10 subjects will donate a 3-5mm skin tissue sample. Longitudinal Patients - 5 blood samples (12 mL each, totaling 60 mL at the following time points: within 48 hours, one week, one month, 6 months and 18 months post injury to coincide with standard visits) and questionnaire. 10 subjects will donate a 3-5mm skin sample. Healthy, pain free volunteers - a one time blood sample (12 mL), vital signs per standard CRU protocol and questionnaire confirming they are healthy.<br>|
| Chronic SCI<br> | Other: blood samples<br>* Chronic patients - a one time blood sample (12 mL) and questionnaire; 10 subjects will donate a 3-5mm skin tissue sample. Longitudinal Patients - 5 blood samples (12 mL each, totaling 60 mL at the following time points: within 48 hours, one week, one month, 6 months and 18 months post injury to coincide with standard visits) and questionnaire. 10 subjects will donate a 3-5mm skin sample. Healthy, pain free volunteers - a one time blood sample (12 mL), vital signs per standard CRU protocol and questionnaire confirming they are healthy.<br>|
| Healthy volunteers<br> | Other: blood samples<br>* Chronic patients - a one time blood sample (12 mL) and questionnaire; 10 subjects will donate a 3-5mm skin tissue sample. Longitudinal Patients - 5 blood samples (12 mL each, totaling 60 mL at the following time points: within 48 hours, one week, one month, 6 months and 18 months post injury to coincide with standard visits) and questionnaire. 10 subjects will donate a 3-5mm skin sample. Healthy, pain free volunteers - a one time blood sample (12 mL), vital signs per standard CRU protocol and questionnaire confirming they are healthy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify candidate biomarkers for pain in the chronic SCI samples. |  | two or more years post injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the temporal relationship of the development of pain and the manifestation of the biomarkers identified |  | two or more years post injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCI, Spinal cord injury, Neuropathic pain, Pain