A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury (NCT01171131) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury
United States96 participantsStarted 2010-04
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial focused on analyzing proteins in the blood to identify biomarkers for chronic traumatic brain injury, could you explain what 'proteomic analysis of plasma' actually means and whether the findings from this completed study might be relevant to understanding my own TBI situation?
2This was labeled a pilot study, which typically means it was a small, early-stage investigation — so how much should I read into any findings that came out of it, and are there larger follow-up studies I should know about?
3Since this study is already completed and wasn't testing a treatment but rather looking for biological markers, is there any way the research results could inform how my condition is monitored or diagnosed going forward?
4Are there any biomarkers that were identified in studies like this one that your practice currently uses — or plans to use — to track the progression of chronic traumatic brain injury in patients like me?
5Given that this trial was observational rather than a treatment trial, what options do exist right now for managing chronic TBI, and are there active treatment trials you'd recommend I look into alongside this kind of biomarker research?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proteomic analysis of plasma
Timeframe: average of 6 months post injury
Trial details
NCT IDNCT01171131
SponsorThe University of Texas Health Science Center, Houston