Brain Training to Enhance Frontal Lobe Reasoning

Not Applicable

Completed

Conditions: Traumatic Brain Injury

Interventions: Behavioral: Brain Training Program 1
Behavioral: Brain Training Program 2

Registration Number: NCT01552473

Lead Sponsor: The University of Texas at Dallas

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 108

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brain Training Program 1	Brain Training Program 1	Training Program focusing on providing educational information of cognitive issues related to TBI
Brain Training Program 2	Brain Training Program 2	Program focuses on strategies to address cognitive issues following TBI

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale-Extended	Pre-training (Baseline) Neuropsychological Test	Assesses disability after brain injury (1 dead to 8 good recovery). A higher score is a better outcome.
Community Integration Questionnaire	Neuropsychological changes from baseline to 10 weeks post-training	To examine short-term effects of treatment on cognition and real-life outcomes relating to how successful someone is able to integrate within their community (0 lowest integration (worst outcome) to 40 maximal integration (best outcome)). A higher score is a better outcome.
Functional Status Exam	Measure at 10 weeks post-training	To examine short-term effects of treatment on outcomes. - (0 highest function (best outcome) to 31 lowest function (worst outcome)). A lower score is a better outcome.
Daneman-Carpenter Reading Span Test	Measure at 10 weeks post-training	Scored as 0 words to 7 words comprehended. Higher scores indicate better comprehension and thus a better outcome. Lower scores indicates a lower degree of comprehension. A higher score is a better outcome.
Hayling Sentence Completion Test	Measure at 10 weeks post-training	To examine short-term effects of treatment on cognition by working memory. The Hayling Sentence Completion test measures response initiation (range 0 best to 30 worst). A lower score is a better outcome.
Awareness Questionnaire	Measure at 10 weeks post-training	To examine short-term effects of treatment on real-life outcomes. This test measures impaired self-awareness after brain injury. The scale ranges from 17 (lowest self-awareness level, worst outcome) to 85 (highest self-awareness level, best outcome). A higher score is a better outcome.

Secondary Outcome Measures

Name	Time	Method
Network Based Statistics in Brain Connectivity	MRI measures taken at 10 weeks and 3 months post-training are combined and compared to baseline MRI yielding one number	Brain network connectivity from functional brain imaging was computed using Network-Based Statistics. Data were adjusted to form one number to characterize the significant connection changes associated with the training. This was accomplished by computing a change score. This change score combined the post-training (10 weeks), and 3-months post-training imaging data and compared that to the baseline (pre-training imaging data). This measure allows for an estimation of the number of statistically increased connections observed between different areas of the brain. A higher score indicates more significant connections and is considered to be a better outcome.
Beck Depression Inventory (BDI)	Measure taken at 10 weeks post-training	To examine short-term effects of treatment on measures current depressive symptoms from 0 (no depressive symptoms (best outcome)) to 63 (maximum depressive symptoms (worst outcome)). A lower score is a better outcome.
Post Traumatic Stress Disorder (PTSD) Checklist	Measure taken at 10 weeks post-training	To examine short-term effects of treatment on self-reported measure of symptoms of posttraumatic stress disorder. The test ranges from 0 minimal stress symptoms to 80 maximum stress symptoms. A lower score is a better outcome.
Alcohol, Smoking and Substance Involvement Screening Test	Measure taken at 10 weeks post-training	To examine short-term effects of treatment on problem substance use. The range is from 0 low levels of problem substance use to 414 (maximum level of problem substance use). A lower score is a better outcome.
Alcohol Use Disorders Identification Test	Measure taken at 10 weeks post-training	To examine short-term effects of treatment on real-life outcomes on alcohol use disorder. The test ranges from 0 lowest use (best outcome) to 40 maximal use (worst outcome). A lower score is a better outcome.
Digit Vigilence Test	Measure taken at 10 weeks post-training	To examine short-term effects of treatment on attention. The test is scored as time in seconds with the lowest amount of time indicating the best performance. A lower score is a better outcome.
Connor-Davidson Resilience Scale	Measure taken at 10 weeks post-training	To examine short-term effects of treatment on resilience. the scores range from 0 (lowest reslience and worst outcome) to 100 (highest resilience and best outcome). A higher score is a better outcome.
Wechsler Memory Scale	Measure taken at 10 weeks post-training	To examine short-term effects of treatment on memory. The scores range from 0 (lowest memory level) to 20 (higher memory level). A higher score is a better outcome.
Wechsler Abbreviated Scale of Intelligence Vocabulary Scale	Measure taken at 10 weeks post-training	To examine short-term effects of treatment on vocabulary ability Score ranges from 20 (a lower level of vocabulary) to 80 (a higher level of vocabulary). A higher score is a better outcome.
Wechsler Abbreviated Scale of Intelligence Matrix Reasoning	Measure taken at 10 weeks post-training	To examine short-term effects of treatment on cognition with fluid reasoning being the measure ranging from 20 (lowest performance) to 80 (highest performance). A higher score is a better outcome.
Wechsler Abbreviated Scale of Intelligence Similarities	Measure taken at 10 weeks post-training	To examine short-term effects of treatment on cognition with a score of 20 indicating lowest similarities performance to 80 indicating the highest similarities performance. A higher score is a better outcome.
Satisfaction With Life Scale	Measure taken at 10 weeks post-training	To examine short-term effects of treatment on real-life outcomes. This ranges from 5 lowest satisfaction with life to 35 highest satisfaction with one's life. A higher score is a better outcome.