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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Georgene Hergenroeder, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01171131
First received: July 21, 2010
Last updated: June 13, 2014
Last verified: June 2014

July 21, 2010
June 13, 2014
April 2010
August 2016   (final data collection date for primary outcome measure)
Proteomic analysis of plasma [ Time Frame: average of 6 months post injury ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01171131 on ClinicalTrials.gov Archive Site
Proteomic analysis of saliva [ Time Frame: average of 6 months post injury ] [ Designated as safety issue: No ]
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.
Same as current
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A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury
A Pilot Study to Identify Biomarkers Associated With Chronic TBI

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.

Not Provided
Observational
Observational Model: Cohort
Not Provided
Retention:   Samples Without DNA
Description:

Saliva sample Blood sample (plasma)

Non-Probability Sample

TIRR Clinics

Traumatic Brain Injury
Other: Blood/saliva sampling
one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)
  • Chronic TBI Patients - Non-penetrating

    Chronic TBI patients should have a history of head trauma manifesting in one or more of the following:

    1. Loss of consciousness
    2. Post-traumatic amnesia
    3. Focal neurologic deficits, seizure
    4. Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance)
    5. Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.) Patients will be excluded from the study if we are unable to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).
    Intervention: Other: Blood/saliva sampling
  • Chronic TBI Patients - Blast

    Chronic TBI Blast injury patients should have a history of head trauma manifesting in one or more of the following:

    1. Loss of consciousness
    2. Post-traumatic amnesia
    3. Focal neurologic deficits, seizure
    4. Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance)
    5. Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.) Patients will be excluded from the study if we are unable to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).
    Intervention: Other: Blood/saliva sampling
  • Healthy Volunteers

    Healthy volunteers include gender, age and race matched volunteers able to provide informed consent who have,

    1. No significant medical history
    2. Take no medications (other than birth control pills)
    3. Fever free
    4. No history of head trauma or recent injury/infection
    5. No history of neurological or psychiatric disorders or alcohol or drug dependency.
    Intervention: Other: Blood/saliva sampling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
August 2016
August 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact: Georgene Hergenroeder, BSN MHA, RN Georgene.W.Hergenroeder@uth.tmc.edu
United States
 
NCT01171131
HSC-MS-09-0334
No
Georgene Hergenroeder, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Georgene Hergenroeder, MHA, RN The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP