ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01171131
Recruitment Status : Enrolling by invitation
First Posted : July 28, 2010
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Georgene Hergenroeder, The University of Texas Health Science Center, Houston

Brief 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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Other: Blood/saliva sampling

Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Pilot Study to Identify Biomarkers Associated With Chronic TBI
Study Start Date : April 2010
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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)



Primary Outcome Measures :
  1. Proteomic analysis of plasma [ Time Frame: average of 6 months post injury ]
    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 :
  1. Proteomic analysis of saliva [ Time Frame: average of 6 months post injury ]
    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)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171131


Locations
United States, Texas
TIRR
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Georgene Hergenroeder, PhD The University of Texas Health Science Center, Houston

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
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data

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

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