Therapeutic Resources for Attention Improvement With Neuroimaging for TBI (TRAIN-TBI)
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|ClinicalTrials.gov Identifier: NCT02082509|
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : December 4, 2018
|Condition or disease|
|Traumatic Brain Injury|
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 Type :||Observational|
|Actual Enrollment :||26 participants|
|Official Title:||Therapeutic Resources for Attention Improvement With Neuroimaging for Traumatic Brain Injury|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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.
- 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)
- Improvement of attention measures via online training program (TAPAT) [ Time Frame: 2 months after enrollment ]
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
- Improvement of overall cognitive functioning [ Time Frame: 2 months after enrollment ]
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,
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): NCT02082509
|United States, California|
|UCSF Mission Bay|
|San Francisco, California, United States, 94158|
|Principal Investigator:||Pratik Mukherjee, MD, PhD||University of California, San Francisco|