Biomarkers for Pain in Spinal Cord Injury (SCI) Patients (SCI Pain)
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ClinicalTrials.gov Identifier: NCT00913471 |
Recruitment Status :
Active, not recruiting
First Posted : June 4, 2009
Last Update Posted : September 21, 2020
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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.
Condition or disease | Intervention/treatment |
---|---|
Traumatic Spinal Cord Injury Neuropathic Pain | Other: blood samples |
Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Biomarkers for Pain in Spinal Cord Injury (SCI) Patients |
Study Start Date : | June 2009 |
Estimated Primary Completion Date : | June 2030 |
Estimated Study Completion Date : | December 2030 |

Group/Cohort | Intervention/treatment |
---|---|
Acute-Longitudinal SCI |
Other: blood samples
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. |
Chronic SCI |
Other: blood samples
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. |
Healthy volunteers |
Other: blood samples
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. |
- To identify candidate biomarkers for pain in the chronic SCI samples. [ Time Frame: two or more years post injury ]
- To identify the temporal relationship of the development of pain and the manifestation of the biomarkers identified [ Time Frame: two or more years post injury ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913471
United States, Texas | |
Memorial Hermann Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Georgene Hergenroeder, PhD | UTHSC-Houston |
Responsible Party: | Georgene Hergenroeder, Associate Professor, Neurosurgery, The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00913471 |
Other Study ID Numbers: |
HSC-MS-07-0452 |
First Posted: | June 4, 2009 Key Record Dates |
Last Update Posted: | September 21, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is no plan to share individual participant data. |
Spinal cord injury SCI Neuropathic pain Pain |
Spinal Cord Injuries Neuralgia Wounds and Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases |
Trauma, Nervous System Peripheral Nervous System Diseases Neuromuscular Diseases Pain Neurologic Manifestations |