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

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ClinicalTrials.gov Identifier: NCT00913471
Recruitment Status : Active, not recruiting
First Posted : June 4, 2009
Last Update Posted : September 21, 2020
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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