Biomarkers for Pain in Spinal Cord Injury (SCI) Patients

Neuropathic Pain Clinical Trial

— SCI Pain  

Official title:

Biomarkers for Pain in Spinal Cord Injury (SCI) Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00913471
• Other study ID #: HSC-MS-07-0452
• Status: Active, not recruiting
• Start date: June 2009
• Est. completion date: December 2030

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2030
• Est. primary completion date: June 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries
• Traumatic Spinal Cord Injury
• Wounds and Injuries

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.

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	The Institute for Rehabilitaion and Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hergenroeder GW, Moore AN, Schmitt KM, Redell JB, Dash PK. Identification of autoantibodies to glial fibrillary acidic protein in spinal cord injury patients. Neuroreport. 2016 Jan 20;27(2):90-3. doi: 10.1097/WNR.0000000000000502. — View Citation

Hergenroeder GW, Redell JB, Choi HA, Schmitt L, Donovan W, Francisco GE, Schmitt K, Moore AN, Dash PK. Increased Levels of Circulating Glial Fibrillary Acidic Protein and Collapsin Response Mediator Protein-2 Autoantibodies in the Acute Stage of Spinal Cord Injury Predict the Subsequent Development of Neuropathic Pain. J Neurotrauma. 2018 Nov 1;35(21):2530-2539. doi: 10.1089/neu.2018.5675. Epub 2018 Jul 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify candidate biomarkers for pain in the chronic SCI samples.		two or more years post injury
Secondary	To identify the temporal relationship of the development of pain and the manifestation of the biomarkers identified		two or more years post injury