Thomas A. Novack

Long-term Neuropsychological Outcome After Traumatic Brain Injury

Objective:To describe neuropsychological outcome 5 years after injury in persons with traumatic brain injury (TBI) who received inpatient medical rehabilitation. To determine the magnitude and pattern neuropsychological recovery from 1 year to 5 years after injury. Design:Longitudinal cohort study with inclusion based on the availability of neuropsychological data at 1 year and 5 years after injury. Setting:National Institute on Disability and Rehabilitation Research Traumatic Brain Injury Model Systems of Care. Participants:One hundred eighty-two persons with complicated mild to severe traumatic brain injury. Primary Outcome Measures:Digits Forward and Backward, Logical Memory I and II, Token Test, Controlled Oral Word Association Test, Symbol Digit Modalities Test, Trail Making Test, Rey Auditory Verbal Learning Test, Visual Form Discrimination, Block Design, Wisconsin Card Sorting Test, and Grooved Pegboard. Results:Significant variability in outcome was found 5 years after TBI, ranging from no measurable impairment to severe impairment on neuropsychological tests. Improvement from 1 year after injury to 5 years was also variable. Using the Reliable Change Index, 22.2% improved, 15.2% declined, and 62.6% were unchanged on test measures. Conclusions:Neuropsychological recovery after TBI is not uniform across individuals and neuropsychological domains. For a subset of persons with moderate to severe TBI, neuropsychological recovery may continue several years after injury with substantial recovery. For other persons, measurable impairment remains 5 years after injury. Improvement was most apparent on measures of cognitive speed, visuoconstruction, and verbal memory.

Amantadine to Improve Neurorecovery in Traumatic Brain Injury-Associated Diffuse Axonal Injury: A Pilot Double-blind Randomized Trial

Background:Traumatic brain injury (TBI) caused by a high-speed transportation accident results in a mechanism of injury commonly described as diffuse axonal injury (DAI), which is associated with a reduction in dopamine turnover in the brain. Because of its affect on both dopamine and N-methyl-D-aspartate (NMDA) channels, amantadine has been the subject of considerable interest and clinical use in acute TBI. Participants:In this study, 35 subjects, who had a TBI in a transportation accident and were initially seen with a Glasgow Coma Scale score of 10 or less within the first 24 hours after admission, were randomly assigned to a double-blind, placebo-controlled, crossover design trial. Main Outcome Measures:Amantadine, 200 mg, or placebo was each administered for 6 weeks (12 weeks total) to patients who were recruited consecutively. Results:There was an improvement in the Mini-Mental Status (MMSE) scores of 14.3 points (P = .0185), Disability Rating Scale (DRS) score of 9.8 points (P = .0022), Glasgow Outcome Scale (GOS) score of 0.8 points (P = .0077), and in the FIM Cognitive score (FIM-cog)™ of 15.1 points (P = .0033) in the group that received amantadine during the first 6 weeks (group 1), but there was no improvement in the second 6 weeks on placebo (P > .05). In group 2 (active drug second 6 weeks), there was an improvement in the MMSE of 10.5 points, in the DRS of 9.4 points (P = .0006), in the GOS of 0.5 points (P = .0231), and in the FIM-cog of 11.3 points (P = .0030, Wilcoxon signed rank) spontaneously in the first 6 weeks on placebo (P = .0015). However, group 2 gained a statistically significant additional 6.3 points of recovery in the MMSE (P = .0409), 3.8 points in the DRS (P = .0099), 0.5 points in the GOS (P = .4008), and 5.2 points in the FIM-cog (P = .0173, Wilcoxon signed rank) between the sixth week and the twelfth week of treatment on the active drug. Conclusions:There was a consistent trend toward a more rapid functional improvement regardless of when a patient with DAI-associated TBI was started on amantadine in the first 3 months after injury.

Influence of early variables in traumatic brain injury on functional independence measure scores and rehabilitation length of stay and charges

Abstract Objective: To determine the relationship between early variables (initial Glasgow Coma Scale [GCS] scores, computed tomography [ct]findings, presence of skeletal trauma, age, length of acute hospitalization) and outcome variables (Functional Independence Measure [FIM] scores, rehabilitation length of stay [LOS], rehabilitation charges) in traumatic brain injury (TBI). Design: Inception cohort. Setting: University tertiary care rehabilitation center. Patients: 91 patients with TBI. Interventions: Inpatient rehabilitation. Main Outcome Measures: FIM, rehabilitation LOS, and rehabilitation charges. Results: Patients in the severely impaired (GCS = 3 to 7) group showed significantly lower ( p = .01) mean admission and discharge motor scores (21.26, 39.83) than patients in the mildly impaired (GCS = 13 to 15) group (38.86, 55.29). Cognitive scores were also significantly lower ( p p p p = .05) scores, and significantly higher ( p = .01) rehabilitation charges. Patients with CT findings of intracranial bleed with skull fracture had longer total LOS (70.88 vs 43.08 days; p p p p = .002; p = .04 after regression analysis) FIM cognitive scores on admission (48.30 vs 27.28) and discharge (64.74 vs 45.78) than those without a fracture. Finally, data available on rehabilitation admission were used to predict discharge outcomes. The percentage of explained variance for each outcome variable is as follows: discharge FIM motor score, 69.5%; discharge FIM cognitive score, 71.2%; rehabilitation LOS, 54.1%; rehabilitation charges, 61.1%. The most powerful predictor of LOS and charges was the admission FIM motor score ( p p = .02) and age ( p = .04). Conclusion: Information readily available on rehabilitation admission, particularly the FIM motor score, may be useful in predicting discharge FIM scores as well as utilization of medical rehabilitation resources. Earlier transfer to rehabilitation may result in higher functional status and lower rehabilitation charges, as well as lower acute hospitalization charges. The presence of extremity fractures encountered during a motor vehicle crash is associated with a more favorable outcome in TBI as evidenced by higher discharge FIM cognitive scores.

Effective serial measurement of cognitive orientation in rehabilitation: the Orientation Log.

OBJECTIVE To introduce a brief quantitative measure of cognitive orientation (to place, time, and situation) developed for daily use at bedside with rehabilitation inpatients. The Orientation Log (O-Log) is a 10-item scale that allows for partial credit based on responsiveness to logical, multiple-choice, or phonemic cueing. It is formatted for rapid visual analysis of orientation trends that can be used to evaluate pharmacologic and cognitive-behavioral interventions. DESIGN Descriptive study of the O-Logs reliability (interrater and internal consistency). SETTING Inpatient rehabilitation center affiliated with a large university medical school. PATIENTS Fifteen neurorehabilitation inpatients. RESULTS For individual items, Spearman rho interrater reliability coefficients ranged from .851 to 1.00. The interrater reliability of the total score was .993. O-Log internal consistency (coefficient alpha) was .922. CONCLUSIONS The O-Log is a reliable and easily administered scale that promises to be a useful tool in monitoring cognitive recovery during rehabilitation.

Major and Minor Depression After Traumatic Brain Injury

OBJECTIVE To examine minor as well as major depression at 1 year posttraumatic brain injury (TBI), with particular attention to the contribution of depression severity to levels of societal participation. DESIGN Observational prospective study with a 2-wave longitudinal component. SETTING Inpatient rehabilitation centers, with 1-year follow up conducted primarily by telephone. PARTICIPANTS Persons with TBI (N=1570) enrolled in the TBI Model System database and followed up at 1-year postinjury. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES FIM, Patient Health Questionnaire-9, Participation Assessment with Recombined Tools-Objective, Glasgow Outcome Scale-Extended, and the Satisfaction With Life Scale. RESULTS Twenty-two percent of the sample reported minor depression, and 26% reported major depression at 1-year post-TBI. Both levels of depression were associated with sex (women), age (younger), preinjury mental health treatment and substance abuse, and cause of injury (intentional). There was a monotonic dose-response relationship between severity of depression and all 1-year outcomes studied, including level of cognitive and physical disability, global outcome, and satisfaction with life. With other predictors controlled, depression severity remained significantly associated with the level of societal participation at 1-year post-TBI. CONCLUSIONS Minor depression may be as common as major depression after TBI and should be taken seriously for its association to negative outcomes related to participation and quality of life. Findings suggest that, as in other populations, minor and major depression are not separate entities, but exist on a continuum. Further research should determine whether people with TBI traverse between the 2 diagnoses as in other patient groups.

Effect of citicoline on functional and cognitive status among patients with traumatic brain injury: Citicoline Brain Injury Treatment Trial (COBRIT).

CONTEXT Traumatic brain injury (TBI) is a serious public health problem in the United States, yet no treatment is currently available to improve outcome after TBI. Approved for use in TBI in 59 countries, citicoline is an endogenous substance offering potential neuroprotective properties as well as facilitated neurorepair post injury. OBJECTIVE To determine the ability of citicoline to positively affect functional and cognitive status in persons with complicated mild, moderate, and severe TBI. DESIGN, SETTING, AND PATIENTS The Citicoline Brain Injury Treatment Trial (COBRIT), a phase 3, double-blind randomized clinical trial conducted between July 20, 2007, and February 4, 2011, among 1213 patients at 8 US level 1 trauma centers to investigate effects of citicoline vs placebo in patients with TBI classified as complicated mild, moderate, or severe. INTERVENTION Ninety-day regimen of daily enteral or oral citicoline (2000 mg) or placebo. MAIN OUTCOME MEASURES Functional and cognitive status, assessed at 90 days using the TBI-Clinical Trials Network Core Battery. A global statistical test was used to analyze the 9 scales of the core battery. Secondary outcomes were functional and cognitive improvement, assessed at 30, 90, and 180 days, and examination of the long-term maintenance of treatment effects. RESULTS Rates of favorable improvement for the Glasgow Outcome Scale-Extended were 35.4% in the citicoline group and 35.6% in the placebo group. For all other scales the rate of improvement ranged from 37.3% to 86.5% in the citicoline group and from 42.7% to 84.0% in the placebo group. The citicoline and placebo groups did not differ significantly at the 90-day evaluation (global odds ratio [OR], 0.98 [95% CI, 0.83-1.15]); in addition, there was no significant treatment effect in the 2 severity subgroups (global OR, 1.14 [95% CI, 0.88-1.49] and 0.89 [95% CI, 0.72-1.49] for moderate/severe and complicated mild TBI, respectively). At the 180-day evaluation, the citicoline and placebo groups did not differ significantly with respect to the primary outcome (global OR, 0.87 [95% CI, 0.72-1.04]). CONCLUSION Among patients with traumatic brain injury, the use of citicoline compared with placebo for 90 days did not result in improvement in functional and cognitive status. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00545662.

Neuropsychological Assessment and Employment Outcome After Traumatic Brain Injury: A Review

While there may be many reasons for obtaining neuropsychological assessment after traumatic brain injury (TBI), prediction of real world functioning is generally a key goal. The present paper reviews 23 studies concerning the relationship between neuropsychological test results and employment outcome after TBI. The review was conducted in accordance with guidelines developed by the Committee on Empirically Supported Practice of Division 40 (Neuropsychology) of the American Psychological Association. Results of the review support a Category A (strongly supported) recommendation for the use of early neuropsychological assessment to predict late employment outcome. Studies of late neuropsychological assessment and subsequent employment outcome and studies of concurrent neuropsychological assessment and employment outcome were inconclusive regarding either support or contraindication for neuropsychological assessment to predict employment outcome. Almost all studies conducted at these late or concurrent time points had significant limitations with regard to study type or adequacy of methodology. However, there is no conceptual basis for believing that neuropsychological findings obtained closer in time to assessment of employment outcome should be less predictive of this outcome than neuropsychological findings obtained at an earlier time.

Driving following traumatic brain injury: prevalence, exposure, advice and evaluations

Survivors of traumatic brain injury often have long-term sensory, cognitive and motor deficits that may impair vehicle operation. However, relatively little is known about the driving status and driving characteristics of brain injury survivors. To better understand driving following traumatic brain injury, a survey of driving status, driving exposure, advice received about driving and evaluations of driving competency was administered to a convenience sample of traumatic brain injury survivors (n = 83). The majority of survey participants had experienced either moderate or severe traumatic brain injuries based on the Glasgow Coma Scale. A total of 60% of the survey participants reported that they were currently active drivers. Most individuals (> 60%) who had returned to driving reported driving every day and more than 50 miles per week. Traumatic brain injury survivors frequently received advice about driving from family members, physicians or non-physician health care professionals, but over half (63%) had not been professionally evaluated for driving competency. The presence of high driving exposure, coupled with a lack of widespread driving fitness testing, suggests that some traumatic brain injury survivors have characteristics that may evaluate their risk for vehicle crashes. However, subsequent prospective studies that directly assess driver safety will be needed to confirm this possibility.

Measuring Outcome in Traumatic Brain Injury Treatment Trials: Recommendations From the Traumatic Brain Injury Clinical Trials Network

Background:Traumatic brain injury (TBI) involves several aspects of a patients condition, including physical, mental, emotional, cognitive, social, and functional changes. Therefore, a clinical trial with individuals with TBI should consider outcome measures that reflect their global status. Methods:We present the work of the National Institute of Child Health and Development–sponsored Traumatic Brain Injury Clinical Trials Network Outcome Measures subcommittee and its choice of outcome measures for a phase III clinical trial of patients with complicated mild to severe TBI. Results:On the basis of theoretical and practical considerations, the subcommittee recommended the adoption of a core of 9 measures that cover 2 different areas of recovery: functional and cognitive. These measures are the Extended Glasgow Outcome Scale; the Controlled Oral Word Association Test; the Trail Making Test, Parts A and B; the California Verbal Learning Test–II; the Wechsler Adult Intelligence Scale–III Digit Span subtest; the Wechsler Adult Intelligence Scale–III Processing Speed Index; and the Stroop Color-Word Matching Test, Parts 1 and 2. Conclusions:The statistical methods proposed to analyze these measures using a global test procedure, along with research and methodological and regulatory issues involved with the use of multiple outcomes in a clinical trial, are discussed.

Cognitive and functional recovery at 6 and 12 months post-TBI

Outcome studies examining recovery from traumatic brain injury (TBI) often fail to provide a clear understanding of the time course of cognitive, emotional, and behavioural recovery. The present study represents an effort to prospectively study individuals with TBI at fixed intervals, specifically 6 and 12 months post-injury with a window of §1 month. Seventy-two individuals with new-onset TBI underwent neuropsychological evaluation and clinical interview at 6 and 12 months post-injury. Results revealed significant improvements in cognitive abilities, including memory, processing speed, language abilities, and constructional skills. There were significant gains in community integration and involvement in productive activities, but limitations in driving activitie s remained. Although individuals with mild± moderate TBI performed better than individuals with severe TBI, both groups demonstrated equivalent rates of recovery across domains. The results of this study provide important information regarding the time course of TBI recovery.Outcome studies examining recovery from traumatic brain injury (TBI) often fail to provide a clear understanding of the time course of cognitive, emotional, and behavioural recovery. The present study represents an effort to prospectively study individuals with TBI at fixed intervals, specifically 6 and 12 months post-injury with a window of +/- 1 month. Seventy-two individuals with new-onset TBI underwent neuropsychological evaluation and clinical interview at 6 and 12 months post-injury. Results revealed significant improvements in cognitive abilities, including memory, processing speed, language abilities, and constructional skills. There were significant gains in community integration and involvement in productive activities, but limitations in driving activities remained. Although individuals with mild-moderate TBI performed better than individuals with severe TBI, both groups demonstrated equivalent rates of recovery across domains. The results of this study provide important information regarding the time course of TBI recovery.