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

This study is currently recruiting participants.
Verified May 2013 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: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
 Other: Blood/saliva sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Pilot Study to Identify Biomarkers Associated With Chronic TBI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Saliva sample Blood sample (plasma)


Estimated Enrollment: 180
Study Start Date: April 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
 Other: Blood/saliva sampling
one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)
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).
 Other: Blood/saliva sampling
one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)
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.
 Other: Blood/saliva sampling
one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

TIRR Clinics

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171131

Contacts
Contact: Georgene Hergenroeder, BSN MHA, RN Georgene.W.Hergenroeder@uth.tmc.edu

Locations
United States, Texas
TIRR Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Georgene Hergenroeder, MHA, RN The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Georgene Hergenroeder, Assistant Professor, Neurosurgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01171131     History of Changes
Other Study ID Numbers: HSC-MS-09-0334
Study First Received: July 21, 2010
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
TBI
Brain Injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013