Biomarkers for Pain in Spinal Cord Injury (SCI) Patients - Full Text View

Sponsor:	The University of Texas Health Science Center, Houston
Collaborator:	The Institute of Rehabilitation and Research (TIRR)
Information provided by (Responsible Party):	Georgene Hergenroeder, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00913471

Purpose

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	Intervention
Traumatic Spinal Cord Injury Neuropathic Pain	Other: blood samples

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Biomarkers for Pain in Spinal Cord Injury (SCI) Patients

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

To identify candidate biomarkers for pain in the chronic SCI samples. [ Time Frame: two or more years post injury ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

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

Estimated Enrollment:	120
Study Start Date:	June 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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:

< 18 years of age
Evidence of brain injury on computed tomography (CT) (SCI patients need to be able to comply with completing the pain survey)
Other medical condition that accounts for chronic pain (i.e. diabetic neuropathy, renal insufficiency, multiple sclerosis, HIV associated neuropathy, alcohol-related neuropathy)
Temperature > 100.5°C
History of infection within the last 30 days (i.e. UTI, URI, pressure sore)
History of Pulmonary Embolus (PE) or deep vein thrombosis (DVT)
Inability to obtain informed consent
Psychiatric problems (patients need to be able to complete the pain survey)
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,

No significant medical history (pain free)
No recent infections
Take no medications
Fever free
Greater than 18 years old

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913471

Contacts

Contact: Georgene W Hergenroeder, MHA, RN

Georgene.W.Hergenroeder@uth.tmc.edu

Locations

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

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

The Institute of Rehabilitation and Research (TIRR)

Investigators

Principal Investigator:

Georgene Hergenroeder, MHA, RN

UTHSC-Houston

More Information

No publications provided

Responsible Party:	Georgene Hergenroeder, Assistant Professor, Neurosurgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00913471 History of Changes
Other Study ID Numbers:	HSC-MS-07-0452
Study First Received:	June 2, 2009
Last Updated:	November 17, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

Spinal cord injury
SCI
Neuropathic pain
Pain

Additional relevant MeSH terms:

Neuralgia
Spinal Cord Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases

Neuromuscular Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012