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OpenTrials
Completed

NCT Number: NCT00913471

Biomarkers for Pain in Spinal Cord Injury Patients

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.

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Key information

Conditions

Traumatic Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

A. Chronic Patients

Inclusion:

  • 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:

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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

    Time frame: two or more years post injury

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • The Institute for Rehabilitaion and Research Foundation

Registry information

Official study title

Biomarkers for Pain in Spinal Cord Injury (SCI) Patients

Acronym: SCI Pain

Important dates

Study start
2009
Primary completion
2013
Study completion
2026
First posted
Jun 4, 2009
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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