Traumatic Brain InjuryTRAIN-TBINCT02082509
Therapeutic Resources for Attention Improvement With Neuroimaging for TBI
An observational study of Traumatic Brain Injury, run by University of California, San Francisco at 1 site in United States.
Trial summary
One of the most common symptoms suffered by traumatic brain injury (TBI) patients is disruption in attention. Lack of attention impacts daily life including academic or professional tasks, and interpersonal relationships. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects with TBI will be recruited from the Bay Area Concussion and Head Injury Program at UCSF or referred to us by colleagues. Healthy controls will be recruited via flyers and referred to us.
Who may be able to join
- (TBI Only) Sustained a blunt TBI at least 1 month prior to enrollment date
- (TBI Only) Currently experiencing at least 1 post-concussive symptom at the time of enrollment
- Ages 8-16
- Must be capable of giving assent
- Must have parental or legal guardian capable of giving informed consent
Who cannot join
- (TBI Only) Injury is less than 1 month from enrollment
- (TBI Only) At time of enrollment, subject does not endorse any post-concussive symptoms
- Younger than 8 years old or older than 16 years old
- Pregnancy
- Pre-injury neurological diagnosis
- Pre-injury diagnosis of an Axis I or Axis II psychiatric disorder other than mild depression
Show all 18Show fewer
- Pre-injury diagnosis of ADD/ADHD
- Pre-injury use of psychotropic medication (including ADD/ADHD medications like Ritalin and Adderall), except for a stable regimen of antidepressants
- Any metal in the body/contraindications for MRI/MEG
- Patient weight >350 pounds due to weight limit of MR scanner
- Hypotensive episode or CT/MR evidence of cerebral ischemia after trauma
- Hemicraniectomy for cerebral swelling
- Surgical evacuation of intra-axial lesions such as contusions/hematomas
- Subjects requiring phenytoin within one week of testing session
- Prisoners
- Non-native English speaker (neurocognitive tests not validated for non-English speakers)
- Visual, auditory, and/or motor impairments that would interfere with cognitive testing
- Current or past drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Resources for Attention Improvement With Neuroimaging for Traumatic Brain Injury
One of the most common symptoms suffered by traumatic brain injury (TBI) patients is disruption in attention. Lack of attention impacts daily life including academic or professional tasks, and interpersonal relationships. The focus of Therapeutic Resources for Attention Improvement with Neuroimaging for Traumatic Brain Injury (TRAIN-TBI) is to investigate the changes in neurological function with special interest in attention after TBI for children ages 8 to 16. This study will be done through advanced neuroimaging procedures, neurocognitive testing, and an online training tool created by The Brain Plasticity Institute. The investigators hypothesize that the training will improve attention in TBI subjects and that the advanced imaging will show corresponding neural connectivity changes, as compared to matched healthy controls.
Read the detailed description
Specific Aim 1: To use advanced functional neuroimaging methods to better understand the nature of attention disruption in patients who have sustained a TBI. We will use imaging data acquired at 3 Tesla (3T) for quantification of regional changes in brain volume over time. The microstructural integrity of white matter tracts will be assessed with diffusion tensor imaging (DTI). Resting state functional MRI (rs-fMRI) from 3T will provide an understanding of the neural networks associated with the brain's baseline activity which may be correlated to cognitive health. We will also try to better understand attention processing in relation to time by employing magnetoencephalography (MEG). By overlaying MEG information on top of structural T1 and T2-weighted MRI sequences, we can get a better overall picture, in both spatial and temporal resolutions, of the brain cognitive tasks. MEG examination will include standard cognitive tasks that rely on intact attention and executive functioning, but are not directly trained by the attention training modules. This allows for assessment of the improvement in functional attention and the ability of training to generalize across related cognitive tasks. All imaging will be corroborated with neuropsychological and neurocognitive testing to assess whether or not abnormalities seen in the imaging are indicative of functionality.
Specific Aim 2: To measure the extent of improvement of patients' attention post cognitive training, and to better understand the processes and timelines that underlie the recovery of attention dysfunction. Comparing the pre- and post-training neurocognitive test results will measure the difference, if any, in attention capacity. These improvements will be correlated to respective advanced imaging. 3T MRI and MEG information from both before and after the cognitive training will be compared to look for any anatomical, functional, and connectivity changes.
Specific Aim 3: To determine which demographic factors (age, race, etc.) and clinical factors (medical history, severity of injury, etc.) contribute to attention impairment, if any. By collecting detailed clinical intake assessments from patients (and/or parents, if applicable) and medical records, as recommended the NIH Common Data Elements for TBI, we will be able to identify any epidemiological variables that significantly contribute to both 1) sustaining attention deficits post-TBI and 2) the propensity for recovery after successful completion of the cognitive training protocol.
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Post-Concussive Symptoms, Brain Imaging, Cognition
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome
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 |
|---|---|---|
| Traumatic Brain Injury (TBI) | Patient who have sustained a TBI over 1 month prior to enrollment, and endorse at least 1 post-concussive symptom at the time of enrollment. | |
| Healthy Controls (no TBI) | Subjects who match the TBI group's demographic characteristics, except that they have not sustained a TBI and they are otherwise physically and mentally healthy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neural connectivity following an attention-based cognitive training program called "TAPAT"
We hypothesize that advanced imaging techniques will allow us to visualize and understand disrupted attention networks (taken before the online training) and how these attention networks recover (as measured after the training). Such imaging methods include: diffusion tensor imaging (DTI, sensitive to the structural integrity of white matter tracks), resting-state functional MRI (rs-fMRI, sensitive to spontaneous fluctuations in blood-oxygen-level-dependent (BOLD) signal due to neurological disease), and magnetoencephalography (MEG, combined with MRI data, detects magnetic fluctuations caused by neuronal firing which produces excellent temporal resolution).
We will compare these patterns of neural connectivity of those with TBI to those without (between-subjects) as well as assess individual differences from before and after the TAPAT training (within-subjects)
Measured: 2 months after enrollment
Secondary outcomes (2)
Improvement of attention measures via online training program (TAPAT)
The Tonic and Phasic Alertness Training (TAPAT) program consists of three consecutive rounds of a continuous performance task in which continually varying centrally-presented scenes, objects or auditory stimuli are briefly displayed and participants are required to respond via a button press when they see a non-target item (90% of trials) or withhold button-press responding when the item is a pre-determined target item (10% of trials). Participants simply sustain attention to the task over a prolonged period of time (tonic attention), ignoring distractions, and inhibiting the pre-potent motor response when they see a target item (phasic attention).
Subjects will do this at-home TAPAT training for 8 weeks, and we hypothesize that the accuracy and the reaction time (RT) of each trial will increase over the course of the 8 weeks. We will compare accuracy and RT of those with TBI to healthy controls
Measured: 2 months after enrollment
Improvement of overall cognitive functioning
Though the TAPAT training is specific to attention, proper attention functioning is needed in a variety of other executive functions. Therefore, we believe that improved attention functioning following the TAPAT training will also improve other domains of executive functions. These will be measured by standardized outcome measures including:
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test, Wechsler Intelligence Scale for Children (WISC-IV) Processing Speed Index and Working Memory Index, CaliforniaVerbal Learning Test for Children (CVLT-C), Attention Network Task (ANT) for ages 11 and up, Attention Network Task for kids (ANT kids) for ages 8-10,
Measured: 2 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pratik Mukherjee, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082509
- Sponsor's protocol ID
- TRAIN-TBI
- Acronym
- TRAIN-TBI
- Status last verified
- Nov 2018
- First submitted
- 6 Mar 2014
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tarapore PE, Findlay AM, Lahue SC, Lee H, Honma SM, Mizuiri D, Luks TL, Manley GT, Nagarajan SS, Mukherjee P. Resting state magnetoencephalography functional connectivity in traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1306-16. doi: 10.3171/2013.3.JNS12398. Epub 2013 Apr 19.
PubMed 23600939Van Vleet TM, DeGutis JM. Cross-training in hemispatial neglect: auditory sustained attention training ameliorates visual attention deficits. Cortex. 2013 Mar;49(3):679-90. doi: 10.1016/j.cortex.2012.03.020. Epub 2012 Apr 9.
PubMed 22578712Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.
PubMed 19220558Hayes EA, Warrier CM, Nicol TG, Zecker SG, Kraus N. Neural plasticity following auditory training in children with learning problems. Clin Neurophysiol. 2003 Apr;114(4):673-84. doi: 10.1016/s1388-2457(02)00414-5.
PubMed 12686276
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Resources for Attention Improvement With Neuroimaging for Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02082509
- Acronym / sponsor ID
- TRAIN-TBI / TRAIN-TBI
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Post-Concussive Symptoms, Brain Imaging, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the most common symptoms suffered by traumatic brain injury (TBI) patients is disruption in attention. Lack of attention impacts daily life including academic or professional tasks, and interpersonal relationships. The focus of Therapeutic Resources for Attention Improvement with Neuroimaging for Traumatic Brain Injury (TRAIN-TBI) is to investigate the changes in neurological function with special interest in attention after TBI for children ages 8 to 16. This study will be done through advanced neuroimaging procedures, neurocognitive testing, and an online training tool created by The Brain Plasticity Institute. The investigators hypothesize that the training will improve attention in TBI subjects and that the advanced imaging will show corresponding neural connectivity changes, as compared to matched healthy controls.
Detailed description
Specific Aim 1: To use advanced functional neuroimaging methods to better understand the nature of attention disruption in patients who have sustained a TBI. We will use imaging data acquired at 3 Tesla (3T) for quantification of regional changes in brain volume over time. The microstructural integrity of white matter tracts will be assessed with diffusion tensor imaging (DTI). Resting state functional MRI (rs-fMRI) from 3T will provide an understanding of the neural networks associated with the brain's baseline activity which may be correlated to cognitive health. We will also try to better understand attention processing in relation to time by employing magnetoencephalography (MEG). By overlaying MEG information on top of structural T1 and T2-weighted MRI sequences, we can get a better overall picture, in both spatial and temporal resolutions, of the brain cognitive tasks. MEG examination will include standard cognitive tasks that rely on intact attention and executive functioning, but are not directly trained by the attention training modules. This allows for assessment of the improvement in functional attention and the ability of training to generalize across related cognitive tasks. All imaging will be corroborated with neuropsychological and neurocognitive testing to assess whether or not abnormalities seen in the imaging are indicative of functionality.
Specific Aim 2: To measure the extent of improvement of patients' attention post cognitive training, and to better understand the processes and timelines that underlie the recovery of attention dysfunction. Comparing the pre- and post-training neurocognitive test results will measure the difference, if any, in attention capacity. These improvements will be correlated to respective advanced imaging. 3T MRI and MEG information from both before and after the cognitive training will be compared to look for any anatomical, functional, and connectivity changes.
Specific Aim 3: To determine which demographic factors (age, race, etc.) and clinical factors (medical history, severity of injury, etc.) contribute to attention impairment, if any. By collecting detailed clinical intake assessments from patients (and/or parents, if applicable) and medical records, as recommended the NIH Common Data Elements for TBI, we will be able to identify any epidemiological variables that significantly contribute to both 1) sustaining attention deficits post-TBI and 2) the propensity for recovery after successful completion of the cognitive training protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury (TBI) | – | –Patient who have sustained a TBI over 1 month prior to enrollment, and endorse at least 1 post-concussive symptom at the time of enrollment. |
| Healthy Controls (no TBI) | – | –Subjects who match the TBI group's demographic characteristics, except that they have not sustained a TBI and they are otherwise physically and mentally healthy. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects with TBI will be recruited from the Bay Area Concussion and Head Injury Program at UCSF or referred to us by colleagues. Healthy controls will be recruited via flyers and referred to us.
Key inclusion criteria (5 listed)
- (TBI Only) Sustained a blunt TBI at least 1 month prior to enrollment date
- (TBI Only) Currently experiencing at least 1 post-concussive symptom at the time of enrollment
- Ages 8-16
- Must be capable of giving assent
- Must have parental or legal guardian capable of giving informed consent
Key exclusion criteria (18 listed)
- (TBI Only) Injury is less than 1 month from enrollment
- (TBI Only) At time of enrollment, subject does not endorse any post-concussive symptoms
- Younger than 8 years old or older than 16 years old
- Pregnancy
- Pre-injury neurological diagnosis
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
Change in neural connectivity following an attention-based cognitive training program called "TAPAT"
Time frame: 2 months after enrollment
We hypothesize that advanced imaging techniques will allow us to visualize and understand disrupted attention networks (taken before the online training) and how these attention networks recover (as measured after the training). Such imaging methods include: diffusion tensor imaging (DTI, sensitive to the structural integrity of white matter tracks), resting-state functional MRI (rs-fMRI, sensitive to spontaneous fluctuations in blood-oxygen-level-dependent (BOLD) signal due to neurological disease), and magnetoencephalography (MEG, combined with MRI data, detects magnetic fluctuations caused by neuronal firing which produces excellent temporal resolution). We will compare these patterns of neural connectivity of those with TBI to those without (between-subjects) as well as assess individual differences from before and after the TAPAT training (within-subjects)
2 secondary outcomes
Improvement of attention measures via online training program (TAPAT)
Time frame: 2 months after enrollment
Improvement of overall cognitive functioning
Time frame: 2 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Background: PubMed 23600939Tarapore PE, Findlay AM, Lahue SC, Lee H, Honma SM, Mizuiri D, Luks TL, Manley GT, Nagarajan SS, Mukherjee P. Resting state magnetoencephalography functional connectivity in traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1306-16. doi: 10.3171/2013.3.JNS12398. Epub 2013 Apr 19.
- Background: PubMed 22578712Van Vleet TM, DeGutis JM. Cross-training in hemispatial neglect: auditory sustained attention training ameliorates visual attention deficits. Cortex. 2013 Mar;49(3):679-90. doi: 10.1016/j.cortex.2012.03.020. Epub 2012 Apr 9.
- Background: PubMed 19220558Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.
- Background: PubMed 12686276Hayes EA, Warrier CM, Nicol TG, Zecker SG, Kraus N. Neural plasticity following auditory training in children with learning problems. Clin Neurophysiol. 2003 Apr;114(4):673-84. doi: 10.1016/s1388-2457(02)00414-5.
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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.
Pratik Mukherjee, MD, PhD principal investigator
University of California, San Francisco
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 Traumatic Brain Injury, run by University of California, San Francisco 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 5 inclusion and 18 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 4 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in neural connectivity following an attention-based cognitive training program called "TAPAT" (time frame: 2 months after enrollment). 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 NCT02082509, which also lists 4 linked publications.
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 4 Dec 2018; AzTrials last refreshed its copy on 7 Nov 2026.