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Traumatic Spinal Cord Injury | Biomarkers for Pain in Spinal Cord Injury (SCI) Patients

Traumatic Spinal Cord Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Spinal Cord Injury

Neuropathic Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:blood samplesChronic 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Acute-Longitudinal SCI

Chronic SCI

Healthy volunteers

Study Status

Active, not recruiting

Start Date: June 2009

Completed Date: December 2020

Phase: N/A

Type: Observational

Design:

Primary Outcome: To identify candidate biomarkers for pain in the chronic SCI samples.

Secondary Outcome: To identify the temporal relationship of the development of pain and the manifestation of the biomarkers identified

Study sponsors, principal investigator, and references

Principal Investigator: Georgene Hergenroeder, MHA, RN

Lead Sponsor: The University of Texas Health Science Center, Houston

Collaborator: The Institute for Rehabilitaion and Research Foundation

More information:https://clinicaltrials.gov/show/NCT00913471

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