Biomarkers for Pain in Spinal Cord Injury (SCI) Patients

NCT00913471 | Active Not Recruiting

• 1 other identifier: HSC-MS-07-0452
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Spinal Cord Injury; Neuropathic Pain

Keywords

Spinal cord injury; SCI; Neuropathic pain; Pain

Outcome Measures

Primary Outcomes (1)

• To identify candidate biomarkers for pain in the chronic SCI samples.

  two or more years post injury

Secondary Outcomes (1)

• To identify the temporal relationship of the development of pain and the manifestation of the biomarkers identified

  two or more years post injury

Study Arms (3)

Acute-Longitudinal SCI

Other: blood samples

Chronic SCI

Other: blood samples

Healthy volunteers

Other: blood samples

Interventions

blood samples OTHER

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.

Acute-Longitudinal SCI; Chronic SCI; Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute and Chronic traumatic spinal cord injury patients and healthy volunteers

You may qualify if:

• \. Two or more years post traumatic SCI with deficit

You may not qualify if:

• \< 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:
• \. 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• The Institute for Rehabilitaion and Research Foundation: collaborator

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Hergenroeder GW, Moore AN, Schmitt KM, Redell JB, Dash PK. Identification of autoantibodies to glial fibrillary acidic protein in spinal cord injury patients. Neuroreport. 2016 Jan 20;27(2):90-3. doi: 10.1097/WNR.0000000000000502.

  PMID: 26629661 BACKGROUND

• Hergenroeder GW, Redell JB, Choi HA, Schmitt L, Donovan W, Francisco GE, Schmitt K, Moore AN, Dash PK. Increased Levels of Circulating Glial Fibrillary Acidic Protein and Collapsin Response Mediator Protein-2 Autoantibodies in the Acute Stage of Spinal Cord Injury Predict the Subsequent Development of Neuropathic Pain. J Neurotrauma. 2018 Nov 1;35(21):2530-2539. doi: 10.1089/neu.2018.5675. Epub 2018 Jul 5.

  PMID: 29774780 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples (120 subjects) and skin tissue biopsy (20 subjects)

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries; Pain

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Georgene Hergenroeder, PhD

  UTHSC-Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neurosurgery

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: June 1, 2009
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)