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

This study is ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00913471

First Posted: June 4, 2009

Last Update Posted: January 18, 2017

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.

Collaborator:

The Institute for Rehabilitaion and Research Foundation

Information provided by (Responsible Party):

Georgene Hergenroeder, The University of Texas Health Science Center, Houston

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 Georgene Hergenroeder, 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 ]

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 ]

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 2020
Estimated Primary Completion Date:	June 2020 (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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
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:

< 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

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


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


Principal Investigator:	Georgene Hergenroeder, MHA, RN	UTHSC-Houston

More Information


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
First Submitted:	June 2, 2009
First Posted:	June 4, 2009
Last Update Posted:	January 18, 2017
Last Verified:	January 2017
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:


Wounds and Injuries Spinal Cord Injuries Neuralgia Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases	Trauma, Nervous System Pain Neurologic Manifestations Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms

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