PTSDNCT01072006
Top-Down Executive Control in Traumatic Brain Injury (TBI), PTSD and Combined
An observational study of PTSD and TBI (Traumatic Brain Injury), run by VA Office of Research and Development at 1 site in United States.
Trial summary
This research investigates processes involved with one being able to focus on relevant information and ignore non-relevant information in veterans with PTSD and those with a history of traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD, TBI (Traumatic Brain Injury)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2011to 21 Apr 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: OEF/OIF Veterans enrolled in the Northern California Health Care System
Who may be able to join
- All subjects will be between 18 and 40 years of age.
- In order to be included in the mTBI group, participants must have sustained between 1 and 3 mild TBIs. The criteria for TBI will be consistent with what the VA currently uses (i.e., American Congress of Rehabilitative Medicine).
- More specifically, patients will have sustained a traumatically induced physiologic disruption of brain function as indicated by at least one of the following:
- any period of loss of consciousness,
- any loss of memory for events immediately before or after the accident,
- any alteration in mental status at the time of the accident, and
Show all 13Show fewer
- focal neurologic deficits.
- Additional criteria for TBI include:
- TBI must have been sustained during OEF or OIF and
- TBI must consist of less than 30 minutes loss of consciousness, posttraumatic amnesia of less than 1 hour, and no positive CT/MRI findings.
- For PTSD group inclusion, psychiatric diagnoses will be established via the PTSD Clinical Checklist- Military (PCL-M) and the Clinician Administered PTSD Scale (CAPS).
- For PTSD/mTBI group inclusion, the above criteria must be met for both PTSD and mTBI.
- Control subjects will be OEF/OIF veterans with a history of exposure to combat without current or previous diagnosis of PTSD and no history of TBI.
Who cannot join
- Subjects who meet diagnostic criteria for drug abuse/dependence over the past year will be excluded.
- Individuals will be excluded if they have neurological confounds (e.g., baseline history of a CNS opportunistic infection, CNS neoplasm, neurosyphilis, current seizure disorder, demyelinating diseases), learning disorder, or current psychiatric disorders involving psychosis (schizophrenia, bipolar disorder with psychosis).
- Patients will also be excluded from the study if they are claustrophobic or are taking cardiovascular medications as these are contraindications for fMRI.
- All 4 subject groups will be matched for age and education.
Trial locations and contacts
1 site in 1 country.
United States1 site
Martinez Outpatient Clinic and Community Living Center, Martinez, CA
Martinez, California, 94553
About this study
Official title: Top-Down Executive Control in TBI, PTSD and Combined TBI/PTSD
This research investigates processes involved with one being able to focus on relevant information and ignore non-relevant information in veterans with PTSD and those with a history of traumatic brain injury. In addition, this study evaluates whether there is an additive effect of having both PTSD and history of TBI on ability to focus attention and inhibit distracting information.
Read the detailed description
Traumatic brain injury (TBI) and PTSD both are characterized by deficits in attention, yet it is unclear as to whether this is related to an inability to focus on relevant information or ignore non-relevant information. History of TBI and PTSD are common to returning soldiers from OEF/OIF and thus is highly relevant to veteran health care. It is unclear how TBI and PTSD separately, and together, affect one's ability to focus attention versus inhibit distracting stimuli. This research investigates this issue by use of a working memory paradigm with functional magnetic resonance imaging (fMRI) that entails the subject being instructed to ignore some stimuli and remember other stimuli resulting in discrete biomarkers of (1) task-related enhancement of neural processes as well as (2) suppression of task-irrelevant neural processes. In this way, the specific aspect of attention in TBI and PTSD will be elucidated in addition to exploring whether PTSD and TBI have an additive, or even synergist, effect when combined.
- Conditions
- PTSD, TBI (Traumatic Brain Injury)
- Keywords
- TBI (Traumatic Brain Injury), PTSD, fMRI, attention
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD) | |
| PTSD Group | PTSD (not TBI) | |
| TBI Group | TBI (no PTSD) | |
| TBI+PTSD Group | Combined TBI history and PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Magnetic Resonance Imaging (fMRI) Correlation
Functional magnetic resonance imaging (fMRI) is used to measure neural activity in participants during attentional task, specifically measured as a bold signal change from rest to attention task. We then calculate the correlation between the bold signal (fMRI) and the PTSD CheckList questionnaire score. (The bold signal from fMRI indirectly reflects the brain's use of glucose, the brain's main energy source.) Correlations are reflected in an R-value, and R-values can range from 0-1, where 0 means there is no correlation (or relationship) between the two measures (here, the two measures are the fMRI brain signal and the PTSD score) and 1 means there is a perfect correlation between the two measures. A high correlation in this study would suggest that the more severe a patient's PTSD symptoms are, the harder their brain is having to work to accomplish the attention task. Separate correlations were analyzed for each group, and the overall R-value for each group is reported below.
Measured: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.
Secondary outcomes (2)
Psychodiagnostic Testing: Post-traumatic Stress Disorder Check List (PCL) Measures the Level of Post-traumatic Stress Disorder (PTSD) Symptoms
The PCL is a 17-item questionnaire that measures PTSD symptoms on a scale that ranges from 17-85 points. The total severity score is reported below. A higher score means a higher level of PTSD symptoms.
Measured: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.
Neuropsychological Testing (Wechsler Test of Adult Reading)
This test provides an estimate of pre-morbid IQ, which is important to report so that the patient sample can be compared to other similar studies for comparable IQ level and so that pre-morbid IQ can be considered as a potential variable. There are 50 items that are each given a score of 1, so the range of scores is 0-50. The raw score is then converted into an estimated IQ score based on age and education. The scores reported below reflect this estimated IQ score, where normal IQ scores range from 75 as low average to 125 as high average.
Measured: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study start7 Jun 2011
- Primary completion1 Dec 2015
- Study completion21 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of California, Berkeley
- Responsible party
- Sponsor
- Investigators
- Juliana V. Baldo, PhD, Principal investigator, Martinez Outpatient Clinic and Community Living Center, Martinez, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072006
- Sponsor's protocol ID
- D7031-W
- Status last verified
- Aug 2017
- First submitted
- 18 Feb 2010
- Last updated
- 12 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sozda CN, Muir JJ, Springer US, Partovi D, Cole MA. Differential learning and memory performance in OEF/OIF veterans for verbal and visual material. Neuropsychology. 2014 May;28(3):347-352. doi: 10.1037/neu0000043. Epub 2013 Nov 18.
PubMed 24245926
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Top-Down Executive Control in TBI, PTSD and Combined TBI/PTSD
- ClinicalTrials.gov ID
- NCT01072006
- Acronym / sponsor ID
- D7031-W
- Conditions
- PTSD, TBI (Traumatic Brain Injury)
- Keywords
- TBI (Traumatic Brain Injury), PTSD, fMRI, attention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of California, Berkeley
- Study start
- 7 Jun 2011 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Posted 24 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research investigates processes involved with one being able to focus on relevant information and ignore non-relevant information in veterans with PTSD and those with a history of traumatic brain injury. In addition, this study evaluates whether there is an additive effect of having both PTSD and history of TBI on ability to focus attention and inhibit distracting information.
Detailed description
Traumatic brain injury (TBI) and PTSD both are characterized by deficits in attention, yet it is unclear as to whether this is related to an inability to focus on relevant information or ignore non-relevant information. History of TBI and PTSD are common to returning soldiers from OEF/OIF and thus is highly relevant to veteran health care. It is unclear how TBI and PTSD separately, and together, affect one's ability to focus attention versus inhibit distracting stimuli. This research investigates this issue by use of a working memory paradigm with functional magnetic resonance imaging (fMRI) that entails the subject being instructed to ignore some stimuli and remember other stimuli resulting in discrete biomarkers of (1) task-related enhancement of neural processes as well as (2) suppression of task-irrelevant neural processes. In this way, the specific aspect of attention in TBI and PTSD will be elucidated in addition to exploring whether PTSD and TBI have an additive, or even synergist, effect when combined.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD) |
| PTSD Group | – | –PTSD (not TBI) |
| TBI Group | – | –TBI (no PTSD) |
| TBI+PTSD Group | – | –Combined TBI history and PTSD |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- OEF/OIF Veterans enrolled in the Northern California Health Care System
Key inclusion criteria (13 listed)
- All subjects will be between 18 and 40 years of age.
- In order to be included in the mTBI group, participants must have sustained between 1 and 3 mild TBIs. The criteria for TBI will be consistent with what the VA currently uses (i.e., American Congress of Rehabilitative Medicine).
- More specifically, patients will have sustained a traumatically induced physiologic disruption of brain function as indicated by at least one of the following:
- Additional criteria for TBI include:
- For PTSD group inclusion, psychiatric diagnoses will be established via the PTSD Clinical Checklist- Military (PCL-M) and the Clinician Administered PTSD Scale (CAPS).
Key exclusion criteria (4 listed)
- Subjects who meet diagnostic criteria for drug abuse/dependence over the past year will be excluded.
- Individuals will be excluded if they have neurological confounds (e.g., baseline history of a CNS opportunistic infection, CNS neoplasm, neurosyphilis, current seizure disorder, demyelinating diseases), learning disorder, or current psychiatric disorders involving psychosis (schizophrenia, bipolar disorder with psychosis).
- Patients will also be excluded from the study if they are claustrophobic or are taking cardiovascular medications as these are contraindications for fMRI.
- All 4 subject groups will be matched for age and education.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Magnetic Resonance Imaging (fMRI) Correlation
Time frame: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.
Functional magnetic resonance imaging (fMRI) is used to measure neural activity in participants during attentional task, specifically measured as a bold signal change from rest to attention task. We then calculate the correlation between the bold signal (fMRI) and the PTSD CheckList questionnaire score. (The bold signal from fMRI indirectly reflects the brain's use of glucose, the brain's main energy source.) Correlations are reflected in an R-value, and R-values can range from 0-1, where 0 means there is no correlation (or relationship) between the two measures (here, the two measures are the fMRI brain signal and the PTSD score) and 1 means there is a perfect correlation between the two measures. A high correlation in this study would suggest that the more severe a patient's PTSD symptoms are, the harder their brain is having to work to accomplish the attention task. Separate correlations were analyzed for each group, and the overall R-value for each group is reported below.
2 secondary outcomes
Psychodiagnostic Testing: Post-traumatic Stress Disorder Check List (PCL) Measures the Level of Post-traumatic Stress Disorder (PTSD) Symptoms
Time frame: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.
Neuropsychological Testing (Wechsler Test of Adult Reading)
Time frame: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24245926Sozda CN, Muir JJ, Springer US, Partovi D, Cole MA. Differential learning and memory performance in OEF/OIF veterans for verbal and visual material. Neuropsychology. 2014 May;28(3):347-352. doi: 10.1037/neu0000043. Epub 2013 Nov 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana V. Baldo, PhD principal investigator
Martinez Outpatient Clinic and Community Living Center, Martinez, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and TBI (Traumatic Brain Injury), run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Magnetic Resonance Imaging (fMRI) Correlation (time frame: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01072006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.