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

• ClinicalTrials.gov Identifier: NCT00913471
• Recruitment Status: Active, not recruiting
• First Posted: June 4, 2009
• Last Update Posted: September 21, 2020
• Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: The Institute for Rehabilitaion and Research Foundation
• Information provided by (Responsible Party): Georgene Hergenroeder, The University of Texas Health Science Center, Houston

Tracking Information

• First Submitted Date: June 2, 2009
• First Posted Date: June 4, 2009
• Last Update Posted Date: September 21, 2020
• Study Start Date: June 2009
• Estimated Primary Completion Date: June 2030 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 3, 2009): To identify candidate biomarkers for pain in the chronic SCI samples. [ Time Frame: two or more years post injury ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: June 3, 2009): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Biomarkers for Pain in Spinal Cord Injury (SCI) Patients
• Official Title: Biomarkers for Pain in Spinal Cord Injury (SCI) Patients

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

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

• Sampling Method: Non-Probability Sample
• Study Population: Acute and Chronic traumatic spinal cord injury patients and healthy volunteers

Condition

• Traumatic Spinal Cord Injury
• Neuropathic Pain

Intervention

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.

Study Groups/Cohorts

• Acute-Longitudinal SCI
  Intervention: Other: blood samples
• Chronic SCI
  Intervention: Other: blood samples
• Healthy volunteers
  Intervention: Other: blood samples

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: June 3, 2009): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2030
• Estimated Primary Completion Date: June 2030 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00913471
• Other Study ID Numbers: HSC-MS-07-0452
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: There is no plan to share individual participant data.

• Responsible Party: Georgene Hergenroeder, The University of Texas Health Science Center, Houston
• Study 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

• PRS Account: The University of Texas Health Science Center, Houston
• Verification Date: September 2020