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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neuropathic Pain; Traumatic Spinal Cord Injury
• Intervention / Treatment: Other: blood samples

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Acute and Chronic traumatic spinal cord injury patients and healthy volunteers

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To identify candidate biomarkers for pain in the chronic SCI samples.	two or more years post injury

Secondary Outcome Measures

Outcome Measure	Time Frame
To identify the temporal relationship of the development of pain and the manifestation of the biomarkers identified	two or more years post injury

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: The Institute for Rehabilitaion and Research Foundation
• Investigators: Principal Investigator: Georgene Hergenroeder, PhD, UTHSC-Houston

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2009
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: June 2, 2009
• First Submitted That Met QC Criteria: June 3, 2009
• First Posted (Estimated): June 4, 2009

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Neuropathic pain; SCI; Spinal cord injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: HSC-MS-07-0452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No