Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Traumatic Spinal Cord Injury Neuropathic Pain Other: blood samples

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers for Pain in Spinal Cord Injury (SCI) Patients
Study Start Date : June 2009
Estimated Primary Completion Date : June 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To identify candidate biomarkers for pain in the chronic SCI samples. [ Time Frame: two or more years post injury ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
blood samples (120 subjects) and skin tissue biopsy (20 subjects)

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Acute and Chronic traumatic spinal cord injury patients and healthy volunteers
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913471


Locations
Layout table for location information
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
The Institute for Rehabilitaion and Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Georgene Hergenroeder, PhD UTHSC-Houston
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Georgene Hergenroeder, Associate Professor, Neurosurgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00913471    
Other Study ID Numbers: HSC-MS-07-0452
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.
Keywords provided by Georgene Hergenroeder, The University of Texas Health Science Center, Houston:
Spinal cord injury
SCI
Neuropathic pain
Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Neuralgia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations