A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— Chronic TBI  

Official title:

A Pilot Study to Identify Biomarkers Associated With Chronic TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171131
• Other study ID #: HSC-MS-09-0334
• Status: Completed
• Start date: April 2010
• Est. completion date: March 3, 2016

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this research is to determine if the biological fluids (blood/saliva) from chronic brain-injured patients (both blast and non-penetrating TBI) contain reproducible protein markers. To accomplish this two populations of chronic TBI patients who are receiving treatment at The Institute for Research and Rehabilitation (TIRR): blast injury victims and non-penetrating TBI will be studied. Using multiple proteomic approaches including mass spectrometry, multiplex ELISAs, and antibody microarrays, as well as RNA profiling, the investigators aim to identify biomarkers in the blood/saliva of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups. Identification of these biochemical changes will give insight into the long-lasting changes associated with head injury, and may identify new targets for treating the associated pathologies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 3, 2016
• Est. primary completion date: March 3, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Chronic TBI patients:

Inclusion Criteria

Have a history of head trauma manifesting in one or more of the following:

• Loss of consciousness

• Post-traumatic amnesia

• Focal neurologic deficits, seizure

• Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance)

• Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.)

Exclusion Criteria

Inability to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).

Healthy volunteers:

Inclusion Criteria

• No significant medical history

• Take no medications (other than birth control pills)

• Fever free

• No history of head trauma or recent injury/infection

• No history of neurological or psychiatric disorders or alcohol or drug dependency.

Exclusion Criteria

• Inability to provide informed consent

• age/gender match not available in TBI cohort

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Other:
• Blood/saliva sampling
one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)

Locations

Country	Name	City	State
United States	TIRR	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomic analysis of plasma	The aim is to identify biomarkers in the blood of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups.	average of 6 months post injury
Secondary	Proteomic analysis of saliva	The aim is to identify biomarkers in the saliva of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups.	average of 6 months post injury