Clinical trial · Observational
Characterization of Human Autoantibody Titers After Central Nervous System Insult
NCT03089749CI-TRIAL-00065656CHAT CNSterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study has been administratively closed by the IRB as of 5/20/2019. This administrative closure was required because of the study expiration on 4/29/2019 and a continuing review application for re-approval of the study was not submitted.
Summary
Brief summary (as posted)
The aim of the study is to quantitate Central Nervous System (CNS) autoantibody development in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial brain surgeries.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Injuries, Traumatic | — | UNRESOLVED | — |
| Intracranial Neoplasm | Intracranial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Spinal Cord Trauma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- Control
- description
- Participants with no history of Traumatic Brain Injury, Traumatic Spinal Cord Injury or Intracranial Neoplasm. A single draw of 5 mL of blood will be obtained as well as demographic information and a brief medical history to act as comparison data to the other groups.
- label
- Traumatic Brain Injury (TBI)
- description
- Patients with Acute Severe TBI (post-resuscitation GCS of 8 or less). Participants will have blood draws at the time points identified below: * At 24h from the time of CNS insult * At 3, 5, 7, 10, 14, 18, 21, 30 days from the time of CNS insult * At 3, 6, and 12 months from the time of CNS insult * Annually for the next four years Total of up to 16 blood draws. In all cases, 5 mL of blood will be obtained from the participant. Demographic data will be collected, including: * Age * Sex * History of prior CNS insult * Clinical indicators of severity including baseline, post-resuscitation Glasgow Coma Scale (GCS) scores for brain injury patients * Radiographic indicators of severity including volume of intracranial hemorrhage, effacement of basal cisterns, amount of midline shift as well as Marshall and Rotterdam CT head scores for TBI. * Outcome data including discharge, 3-, 6-, and 12-month extended Glasgow Outcome Scale (GOS) scores
- label
- Spinal Cord Injury (SCI)
- description
- Patients with acute spinal cord injury (SCI) (post-resuscitation ASIA score of C, B or A). Participants will have blood draws at the time points identified below: * At 24h from the time of CNS insult * At 3, 5, 7, 10, 14, 18, 21, 30 days from the time of CNS insult * At 3, 6, and 12 months from the time of CNS insult * Annually for the next four years Total of up to 16 blood draws. In all cases, 5 mL of blood will be obtained. Demographic data will be collected, including: * Age * Sex * History of prior CNS insult * Clinical indicators of severity including baseline post-resuscitation American Spinal Injury Association (ASIA) score and ASIA impairment scale (AIS) grade for patients with spinal cord injury (SCI) * Radiographic indicators of severity including the degree of cord compression, area of cord signal change and the SFGH MRI scale will be employed. * Outcome data including discharge, 3-, 6-, and 12-month ASIA scores for SCI patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a severe traumatic brain injury * Have spinal cord injury ASIA grade A, B or C * Undergoing resection of intra-axial brain tumors Exclusion Criteria: * Participant who is pregnant
References
Publications (6)
- BACKGROUNDRobinson AP, Harp CT, Noronha A, Miller SD. The experimental autoimmune encephalomyelitis (EAE) model of MS: utility for understanding disease pathophysiology and treatment. Handb Clin Neurol. 2014;122:173-89. doi: 10.1016/B978-0-444-52001-2.00008-X. PMID 24507518
- BACKGROUNDBecker KJ, Kindrick DL, Lester MP, Shea C, Ye ZC. Sensitization to brain antigens after stroke is augmented by lipopolysaccharide. J Cereb Blood Flow Metab. 2005 Dec;25(12):1634-44. doi: 10.1038/sj.jcbfm.9600160. PMID 15931160
- BACKGROUNDBecker KJ, Kalil AJ, Tanzi P, Zierath DK, Savos AV, Gee JM, Hadwin J, Carter KT, Shibata D, Cain KC. Autoimmune responses to the brain after stroke are associated with worse outcome. Stroke. 2011 Oct;42(10):2763-9. doi: 10.1161/STROKEAHA.111.619593. Epub 2011 Jul 28. PMID 21799171
- BACKGROUNDGiunta B, Obregon D, Velisetty R, Sanberg PR, Borlongan CV, Tan J. The immunology of traumatic brain injury: a prime target for Alzheimer's disease prevention. J Neuroinflammation. 2012 Aug 1;9:185. doi: 10.1186/1742-2094-9-185. PMID 22849382
- BACKGROUNDNoble LJ, Wrathall JR. Distribution and time course of protein extravasation in the rat spinal cord after contusive injury. Brain Res. 1989 Mar 13;482(1):57-66. doi: 10.1016/0006-8993(89)90542-8. PMID 2706482
- BACKGROUNDHayes KC, Hull TC, Delaney GA, Potter PJ, Sequeira KA, Campbell K, Popovich PG. Elevated serum titers of proinflammatory cytokines and CNS autoantibodies in patients with chronic spinal cord injury. J Neurotrauma. 2002 Jun;19(6):753-61. doi: 10.1089/08977150260139129. PMID 12165135