Traumatic Spinal Cord InjurySCI PainNCT00913471
Biomarkers for Pain in Spinal Cord Injury Patients
An observational study of Traumatic Spinal Cord Injury and Neuropathic Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Spinal Cord Injury, Neuropathic Pain
- What is being tested?
- blood samples
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acute and Chronic traumatic spinal cord injury patients and healthy volunteers
Who may be able to join
- 1. Two or more years post traumatic SCI with deficit
- 1. Initial traumatic SCI with deficit
Who cannot join
- < 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)
Show all 16Show fewer
- 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
- Longitudinal, Prospective Cohort Patients:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers for Pain in Spinal Cord Injury (SCI) Patients
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.
- Conditions
- Traumatic Spinal Cord Injury, Neuropathic Pain
- Being tested
- blood samples
- Keywords
- Spinal cord injury, SCI, Neuropathic pain, Pain
- Medical subject headings
- Neuralgia, Spinal Cord Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
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 group | Role | What they receive |
|---|---|---|
| Acute-Longitudinal SCI | Not described Receives: Other: blood samples | |
| Chronic SCI | Not described Receives: Other: blood samples | |
| Healthy volunteers | Not described Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify candidate biomarkers for pain in the chronic SCI samples.
Measured: two or more years post injury
Secondary outcomes (1)
To identify the temporal relationship of the development of pain and the manifestation of the biomarkers identified
Measured: two or more years post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2013
- Study completionJun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Institute for Rehabilitaion and Research Foundation
- Responsible party
- Principal investigator, Georgene Hergenroeder, The University of Texas Health Science Center, Houston
- Investigators
- Georgene Hergenroeder, PhD, Principal investigator, UTHSC-Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913471
- Sponsor's protocol ID
- HSC-MS-07-0452
- Acronym
- SCI Pain
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2009
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Publications
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.
PubMed 26629661Hergenroeder 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.
PubMed 29774780
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Pain in Spinal Cord Injury (SCI) Patients
- ClinicalTrials.gov ID
- NCT00913471
- Acronym / sponsor ID
- SCI Pain / HSC-MS-07-0452
- Conditions
- Traumatic Spinal Cord Injury, Neuropathic Pain
- Keywords
- Spinal cord injury, SCI, Neuropathic pain, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- The Institute for Rehabilitaion and Research Foundation
- Study start
- Jun 2009 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2026 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute-Longitudinal SCI | – | Other: blood samples |
| Chronic SCI | – | Other: blood samples |
| Healthy volunteers | – | Other: blood samples |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute and Chronic traumatic spinal cord injury patients and healthy volunteers
Key inclusion criteria (2 listed)
- 1. Two or more years post traumatic SCI with deficit
- 1. Initial traumatic SCI with deficit
Key exclusion criteria (16 listed)
- < 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplesChronic 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. | Other | Acute-Longitudinal SCI, Chronic SCI, Healthy volunteers |
Primary outcome
To identify candidate biomarkers for pain in the chronic SCI samples.
Time frame: two or more years post injury
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 26629661Hergenroeder 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.
- Background: PubMed 29774780Hergenroeder 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
Related trials for Traumatic Spinal Cord Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgene Hergenroeder, PhD principal investigator
UTHSC-Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Spinal Cord Injury and Neuropathic Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify candidate biomarkers for pain in the chronic SCI samples. (time frame: two or more years post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00913471, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.