Clinical trial NCT01552473: Brain Training to Enhance Frontal Lobe Reasoning
Official title: Brain Training to Enhance Frontal Lobe Reasoning in Soldiers and Civilian Adults With TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: TBI
Traumatic Brain Injury
combat related injury
blast injury
concussion
sleep problems
attention problems
memory problems
headaches
dizziness
OEF
OIF
Veterans
Civilian
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
name: Congressionally Directed Medical Research Programs
First posted: 2012-03-13
Enrollment: 108
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to improve the ability to diagnose and to achieve higher-levels of functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12 months).

Detailed description: In the current randomized control trial, we study the efficacy of a functionally relevant cognitive training program applied to individuals who are experiencing the effects of chronic TBI. The top-down training program labeled SMART (Strategic Memory Advanced Reasoning Training) adopts an integrative approach to train functionally relevant complex reasoning abilities (versus specific skills). This integrative approach focused on frontal lobe functions has shown promising results in a preliminary study. SMART is compared to an equally engaging education-based program labeled BHW (Brain Health Workshop). Both SMART and BHW are short-term, intensive (18 h of training over 8 weeks) group training programs that are comparable with regard to training time, amount of information, group discussions, and homework assignments. The overall goal of this trial is to examine how training integrative frontal lobe-mediated processes might improve functioning in brain injury survivors, including military service and civilian populations. We include a range of individuals with different injury types and functional abilities. We use a broad variety of assessment tools, including cognitive, neuroimaging, and functional measures, to compare the training groups.

Our overall goal is to improve the fidelity of TBI diagnoses and to achieve higher levels of functional recovery in soldiers and civilians who have suffered mild to moderate TBIs and are at the chronic stage of brain recovery. This study is also to determine the efficacy of an empirically and theoretically driven framework to enhance frontal lobe-mediated reasoning ability in individuals with TBI, given a relatively short training duration, on trained and untrained cognitive skills, on brain changes, and on measures of real-life function. Toward these aims, this trial is enrolling both soldiers and civilians with a TBI (approximately 50 mild and 50 moderate chronic TBI patients). We use cognitive tests (assessing memory, reasoning, and comprehension abilities), functional MRI scans (performing tests of cognitive function while the subject is receiving an MRI scan), and white matter maps constructed using diffusion tensor imaging (DTI) scans. The MRI scans will be used to provide biomarkers of the contributions of different brain regions to performing cognitive tasks (e.g., memory, reasoning, etc.), as well as assessments of brain efficiency, functional brain connectivity, and brain morphology. We use these measurements to gain an understanding of each individual's cognitive skills and neural measures prior to cognitive intervention. These measures also serve as indicators of the baseline function of each soldier or civilian, to be compared with after intervention, at which point they undergo post-training cognitive, MRI, and DTI assessments, enabling us to make outcome comparisons between the two different cognitive interventions. Finally, we conduct a follow-up assessment with neuropsychological and cognitive measures and neuroimaging 3 months after the interventions to assess how individuals maintain any functional changes that may occur because of the cognitive interventions.

We are targeting this intervention toward mild and moderate TBI participants, who have relatively high functioning skills. The demands of the training can be too high for some individuals falling into the more severe range, in the frequency, duration, and type of strategies and skills emphasized. We also aim to address the high level of need placed upon studies of milder TBI cases, particularly with military populations. This priority is also emphasized by the sponsoring agency, the US Department of Defense, advocating for more studies of mild TBI under the funding mechanism supporting this work.

Eligibility criteria: Inclusion Criteria:

* 19-65 years of age
* Sustained a traumatic brain injury at least 6 months previously
* Comprehend simple instructions, perform tasks and take part in intervention
* Read, speak and comprehend English
* Participate in tasks involving motor abilities such as use of at least one arm or hand

Exclusion Criteria:

* Not proficient in reading, comprehending or speaking English
* Pre-existing Cerebral Palsy, Mental Retardation, Autism, Epilepsy, Schizophrenia, or Pervasive Developmental Disorder
* Individuals with Psychosis, Active Behavioral Disorder, or uncontrolled epilepsy
* Women who are pregnant

Primary outcomes:
measure: Glasgow Outcome Scale-Extended
timeFrame: Pre-training (Baseline) Neuropsychological Test
measure: Community Integration Questionnaire
timeFrame: Neuropsychological changes from baseline to 10 weeks post-training
measure: Functional Status Exam
timeFrame: Measure at 10 weeks post-training
measure: Daneman-Carpenter Reading Span Test
timeFrame: Measure at 10 weeks post-training
measure: Hayling Sentence Completion Test
timeFrame: Measure at 10 weeks post-training
measure: Awareness Questionnaire
timeFrame: Measure at 10 weeks post-training
Secondary outcomes:
measure: Network Based Statistics in Brain Connectivity
timeFrame: MRI measures taken at 10 weeks and 3 months post-training are combined and compared to baseline MRI yielding one number
measure: Beck Depression Inventory (BDI)
timeFrame: Measure taken at 10 weeks post-training
measure: Post Traumatic Stress Disorder (PTSD) Checklist
timeFrame: Measure taken at 10 weeks post-training
measure: Alcohol, Smoking and Substance Involvement Screening Test
timeFrame: Measure taken at 10 weeks post-training
measure: Alcohol Use Disorders Identification Test
timeFrame: Measure taken at 10 weeks post-training
measure: Digit Vigilence Test
timeFrame: Measure taken at 10 weeks post-training
measure: Connor-Davidson Resilience Scale
timeFrame: Measure taken at 10 weeks post-training
measure: Wechsler Memory Scale
timeFrame: Measure taken at 10 weeks post-training
measure: Wechsler Abbreviated Scale of Intelligence Vocabulary Scale
timeFrame: Measure taken at 10 weeks post-training
measure: Wechsler Abbreviated Scale of Intelligence Matrix Reasoning
timeFrame: Measure taken at 10 weeks post-training
measure: Wechsler Abbreviated Scale of Intelligence Similarities
timeFrame: Measure taken at 10 weeks post-training
measure: Satisfaction With Life Scale
timeFrame: Measure taken at 10 weeks post-training
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Center for BrainHealth
state: Texas
Study officials:
affiliation: University of Texas
name: Daniel Krawcyzk, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krawczyk DC, Marquez de la Plata C, Schauer GF, Vas AK, Keebler M, Tuthill S, Gardner C, Jantz T, Yu W, Chapman SB. Evaluating the effectiveness of reasoning training in military and civilian chronic traumatic brain injury patients: study protocol. Trials. 2013 Jan 30;14:29. doi: 10.1186/1745-6215-14-29.