Clinical trial NCT00913471: Biomarkers for Pain in Spinal Cord Injury (SCI) Patients
Official title: Biomarkers for Pain in Spinal Cord Injury (SCI) Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Traumatic Spinal Cord Injury
Neuropathic Pain
Keywords: Spinal cord injury
SCI
Neuropathic pain
Pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: The Institute for Rehabilitaion and Research Foundation
First posted: 2009-06-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute and Chronic traumatic spinal cord injury patients and healthy volunteers

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.


Eligibility criteria: 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

Primary outcomes:
measure: To identify candidate biomarkers for pain in the chronic SCI samples.
timeFrame: two or more years post injury
Secondary outcomes:
measure: To identify the temporal relationship of the development of pain and the manifestation of the biomarkers identified
timeFrame: two or more years post injury
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: UTHSC-Houston
name: Georgene Hergenroeder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.