Characterization of Human Autoantibody Titers After Central Nervous System Insult

Study Overview
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Brief Summary
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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.

Detailed Description
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Study Objectives: We aim to: Quantitate CNS autoantibody development in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial brain surgeries. We also aim to characterize the temporal course of this response. Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity. Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production.

Official Title
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Characterization of Human Autoantibody Titers After Central Nervous System Insult

Conditions
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Intracranial Neoplasm, Brain Injuries, Traumatic, Spinal Cord Trauma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Traumatic Brain Injury (TBI)<br>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 | |
| Control<br>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. | |
| Spinal Cord Injury (SCI)<br>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 | |
| Intracranial Neoplasm<br>Patients undergoing resection of intra-axial brain tumors (commonly gliomas such as glioblastoma multiforme, astrocytomas and oligodendrogliomas). All 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, Karnofsky and Modified Rankin performance status scores for oncology patients. Radiographic indicators of severity including the pre- and postoperative tumor volumes that will be quantitated. Outcome data including discharge, 3-, 6-, and 12-month Karnofsky and Modified Rankin scores for oncology patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitate Autoantibodies | Quantitate CNS autoantibody development and temporal course in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial brain surgeries. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autoantibody Correlation | Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity. | 5 years | 
| Autoantibody Production and History | Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production. | 5 years |