Characterization of Human Autoantibody Titers After Central Nervous System Insult (CHAT CNS)

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ClinicalTrials.gov Identifier: NCT03089749

Recruitment Status : Terminated (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.)

First Posted : March 24, 2017

Last Update Posted : April 14, 2023

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Sponsor:

Information provided by (Responsible Party):

University of Utah

Study Description

Brief Summary:

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.

Condition or disease
Brain Injuries, Traumatic Spinal Cord Trauma Intracranial Neoplasm

Detailed Description:

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	63 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Characterization of Human Autoantibody Titers After Central Nervous System Insult
Study Start Date :	May 2015
Actual Primary Completion Date :	May 20, 2019
Actual Study Completion Date :	May 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Control 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.
Traumatic Brain Injury (TBI) 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
Spinal Cord Injury (SCI) 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 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Biospecimen Retention: Samples Without DNA

Plasma

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Study population includes patients admitted to the University of Utah and its covered entities.

Criteria

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

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): NCT03089749

Locations

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United States, Utah
University of Utah Hospital
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

University of Utah

Investigators

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Principal Investigator:	Gregory WJ Hawryluk, MD, Ph.D.	University of Utah

More Information

Publications:

Robinson 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.

Becker 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.

Becker 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.

Giunta 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.

Noble 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.

Hayes 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.

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Responsible Party:	University of Utah
ClinicalTrials.gov Identifier:	NCT03089749
Other Study ID Numbers:	CHAT-00081214
First Posted:	March 24, 2017 Key Record Dates
Last Update Posted:	April 14, 2023
Last Verified:	April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

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Brain Neoplasms Brain Injuries Brain Injuries, Traumatic Spinal Cord Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma	Trauma, Nervous System Wounds and Injuries Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Spinal Cord Diseases

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