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Trial record 16 of 157 for:    (Dementia pugilistica OR chronic traumatic encephalopathy)

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

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ClinicalTrials.gov Identifier: NCT01171131
Recruitment Status : Enrolling by invitation
First Posted : July 28, 2010
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Georgene Hergenroeder, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date July 21, 2010
First Posted Date July 28, 2010
Last Update Posted Date January 16, 2019
Study Start Date April 2010
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 26, 2010)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01171131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 26, 2010)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury
Official Title A Pilot Study to Identify Biomarkers Associated With Chronic TBI
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Saliva sample Blood sample (plasma)
Sampling Method Non-Probability Sample
Study Population TIRR Clinics
Condition Traumatic Brain Injury
Intervention Other: Blood/saliva sampling
one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: July 26, 2010)
180
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01171131
Other Study ID Numbers HSC-MS-09-0334
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data
Responsible Party Georgene Hergenroeder, The University of Texas Health Science Center, Houston
Study Sponsor The University of Texas Health Science Center, Houston
Collaborators Not Provided
Investigators
Principal Investigator: Georgene Hergenroeder, PhD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date January 2019