Characterization of Human Autoantibody Titers After Central Nervous System Insult

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03089749

Acronym

CHAT CNS

Enrollment

Registered

2017-03-24

Start date

2015-05-31

Completion date

2019-05-20

Last updated

2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic, Intracranial Neoplasm, Spinal Cord Trauma

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Quantitate Autoantibodies	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

Measure	Time frame	Description
Autoantibody Correlation	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	5 years	Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production.

Countries

United States

Outcome results