Characterization of Human Autoantibody Titers After Central Nervous System Insult

Brain Injuries, Traumatic Clinical Trial

— CHAT CNS  

Official title:

Characterization of Human Autoantibody Titers After Central Nervous System Insult

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03089749
• Other study ID #: CHAT-00081214
• Status: Terminated
• Start date: May 2015
• Est. completion date: May 20, 2019

Study information

• Verified date: April 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study Objectives:

We aim to:

1. 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.

2. Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity.

3. Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: May 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Brain Neoplasms
• Intracranial Neoplasm
• Spinal Cord Injuries
• Spinal Cord Trauma

Locations

Country	Name	City	State
United States	University of Utah Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Autoantibody Correlation	Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity.	5 years
Secondary	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