Outcomes of Six Specific Types of Post-Hospital Brain Injury Rehabilitation Programs.

OBJECTIVE: Evaluate outcomes of intensive posthospital brain injury rehabilitation programs compared to supported living (SL) programs; explore variations in outcome by diagnostic category (traumatic brain injury, stroke, and other acquired brain injury [ABI]) and specific program type. SETTING: Data were obtained from Residential Neurobehavioral, Residential Neurorehabilitation, Home and Community Neurorehabilitation, Day Treatment, Outpatient Neurorehabilitation, and SL programs serving individuals with ABI. PARTICIPANTS: A total of 2120 individuals with traumatic brain injury, stroke, or other ABI participated in this study. MAIN MEASURES: The main measures are sex, age, time since injury, and Mayo-Portland Adaptability Inventory (4th edition; MPAI-4). DESIGN: Retrospective analyses of demographic variables and MPAI-4 Total, index, and subscale Rasch-derived T-scores on admission and discharge. RESULTS: Gains on MPAI-4  Total T-scores were significantly greater for the intensive rehabilitation (IR) group in comparison to stable functioning in the SL group (F = 236.69, P < .001, partial η2 = .101) while controlling for admission/time 1 scores; similar results were found for MPAI-4 indices and subscales. For the IR cohort, discharge scores differed by diagnostic category after controlling for admission scores for the Total MPAI-4 T-score (F = 22.65, P < .001, partial η2 = .025), as well as all indices and subscales. A statistically significant interaction between program type and diagnostic group on discharge MPAI-4 Total T-scores (F = 2.55, P = .018, partial η2 = .01) after controlling for admission scores indicated that differing outcomes across diagnoses also varied by program type. Varying significant main effects and interactions were apparent for MPAI-4 indices and subscales with generally small effect sizes. CONCLUSIONS: Significant gains on MPAI-4 variables across IR program types compared to no change over a comparable period of time for SL programs supports the effectiveness of posthospital brain injury rehabilitation. This finding in the presence of small effect sizes on outcome variables for program type and for significant interactions between program type and diagnostic category suggests that participants generally were appropriately matched to program type and benefited from interventions provided through specific program types.

Distinguishing Characteristics of Admissions to Various Types of Posthospital Brain Injury Rehabilitation Programs.

OBJECTIVE: Describe and compare the demographic characteristics and disability profiles of individuals admitted to 6 types of posthospital brain injury rehabilitation (PHBIR) programs. SETTING: Data from Residential Neurobehavioral, Residential Neurorehabilitation, Home and Community Neurorehabilitation, Day Treatment, Outpatient Neurorehabilitation, and Supported Living programs serving individuals with acquired brain injury (ABI). PARTICIPANTS: Two thousand twenty-eight individuals with traumatic brain injury (TBI), stroke, or other ABI. MAIN MEASURES: Sex, age, time since injury, and Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4). DESIGN: Retrospective analyses of demographic variables and MPAI-4 Total, Index, and subscale Rasch-derived T-scores on admission comparing diagnostic categories and program types within diagnostic categories. RESULTS: Participants with TBI were predominantly male, and those with stroke were generally older. Admissions to more intensive and supervised programs (residential neurobehavioral and residential neurorehabilitation) generally showed greater disability than admissions to home and community programs who were more disabled than participants in day treatment and outpatient programs. Residential neurobehavioral and supported living program participants generally were male and had TBI. Home and community admissions tended to be more delayed than residential neurorehabilitation admissions. The majority of those with other ABI were admitted to outpatient rather than more intensive programs. Additional analyses demonstrated significant differences in MPAI-4 profiles among the various program types. CONCLUSIONS: Admissions with TBI, stroke, and other ABI to PHBIR differ in demographic factors and disability profiles. When examined within each diagnostic category, demographic features and disability profiles also distinguish among admissions to the various program types. Results provide insights about decision-making in referral patterns to various types of PHBIR programs, although other factors not available for analysis (eg, participant/family preference, program, and funding availability) likely also contribute to admission patterns.

Rasch Analysis of the Mayo-Portland Adaptability Inventory for Posthospital Brain Injury Rehabilitation.

OBJECTIVES: (1) Reexamine the item structure and reliability of the Mayo-Portland Adaptability Inventory (4th ed; MPAI-4) through Rasch analysis of admission and discharge scores for a large sample of adults with acquired brain injury (ABI) who participated in various types of posthospital brain injury rehabilitation (PHBIR) programs; (2) compare differential item functioning (DIF) for traumatic brain injury (TBI), stroke and other ABI; and (3) explore the viability of more specific subscales in addition to the established indices. SETTING: Data from Residential Neurobehavioral, Residential Neurorehabilitation, Home and Community, Day Treatment, and Outpatient rehabilitation programs serving individuals with ABI. PARTICIPANTS: A total of 2154 individuals with TBI, stroke, or other ABI. DESIGN: Retrospective analysis of de-identified admission and discharge data from the Foundation to Advance Brain Rehabilitation (FABR) consortium database. MAIN MEASURE: MPAI-4. RESULTS: After adjusting 4 misfitting items and eliminating 20 misfitting persons, the MPAI-4 demonstrated real person reliability/separation = 0.93/3.52 and real item reliability/separation = 1.00/24.02. Independent Rasch analyses by diagnostic category found similar reliabilities and separations. Residual item correlations and principal component analysis of residuals (PCAR) indicated areas of local dependence arranged hierarchically reflecting the full-scale item hierarchy and providing the basis for 3 new subscales of Physical Abilities, Cognitive Abilities, and Autonomy. DIF across diagnostic categories revealed differences in item elevations characteristic of typical patients in each category. Measure means and SDs were very similar across categories. CONCLUSIONS: MPAI-4 items demonstrate very good person and item reliabilities for individuals with TBI, stroke, and other ABI at a level that supports individual evaluation. Variations in item calibrations across diagnostic categories reflect the differential characteristics of typical patients within categories. The entire measure provides an overall assessment of common sequalae of ABI, and standard indices used in combination with newly derived subscales provide more specific assessments of rehabilitation needs for treatment planning.

Assessing the benefits and risks of amantadine for irritability and aggression after traumatic brain injury.

OBJECTIVE: To quantify the benefits versus harms of amantadine in the treatment of irritability and aggression following traumatic brain injury. METHODS: Secondary outcome data from a randomized controlled multisite trial of amantadine 100 mg twice daily were used to calculate number-needed-to-treat (NNT). Given prior findings of positive clinician-perceived effects and low incidence of adverse events, we hypothesized low number-needed-to-treat for benefit (NNTB; high benefit) and high number-needed-to-treat for harm (NNTH; low risk) based on the clinician ratings, supporting the use of amantadine in clinical practice. Specifically, NNTB values were calculated using number of individuals with improvement on the Clinician Global Impressions-Global Improvement scale (GI). NNTB values were computed using number of individuals with worsening on the GI and experiencing serious and any adverse events. RESULTS: Based on clinician ratings, on average for every six patients treated with amantadine rather than placebo, one extra patient would be expected to improve (NNTB = 6.4; 95% confidence interval [CI]: [3.3-76.8]). More participants in the placebo group worsened than in the amantadine group, but the result was not statistically significant (NNTH = -92.4; 95% CI: [NNTB -32.9 to infinity to NNTH -19.2]). The amantadine and placebo groups did not differ on the numbers of adverse events experienced during the trial. CONCLUSION: Clinician ratings suggest modest benefit of amantadine 100 mg twice daily with low risk to appropriately selected patients with adequate renal clearance. Thus, amantadine should be considered a treatment option for the experienced brain injury clinician. These data may support treatment decisions when a pharmaceutical agent is being considered to control irritability/aggression.

An Observational Cohort Study of the Role of Level of Effort in Post-Acute Brain Injury Rehabilitation.

OBJECTIVE: To investigate the role of participant level of effort (LoE) on outcome in post-acute brain injury rehabilitation with the hypothesis that greater effort is associated with more positive outcomes. DESIGN: Observational cohort study. SETTING: Comprehensive integrated rehabilitation program for brain injury within a skilled nursing facility. PARTICIPANTS: Consecutive admissions with acquired brain injury (N=101). INTERVENTIONS: Individualized interdisciplinary brain injury rehabilitation; therapist rating of participant LoE with Acquired Brain Injury LoE Scale (ABI-LoES) during physical therapy, occupational therapy, and speech and language pathology sessions. MAIN OUTCOME MEASURES: Mayo-Portland Adaptability Inventory, fourth edition (MPAI-4); Supervision Rating Scale (SRS). RESULTS: Linear regression showed that discharge MPAI-4 Total T scores were significantly associated with mean ABI-LoES rating, admission MPAI-4 Total T scores, age at admission, and days from injury but not with standard deviation of ABI-LoES rating, sex, injury type, length of stay, or treatment before or during the COVID-19 pandemic. Discharge SRS scores were significantly associated with mean ABI-LoES rating, admission SRS scores, and age. A 1-unit increase in mean ABI-LoES rating was associated with 5.1-unit lower discharge MPAI-4 Total T scores and 1.5 lower discharge SRS scores, after controlling for other variables. Logistic regression showed that the odds of achieving a minimal clinically important difference on the MPAI-4 were 8.34 times higher with each 1-unit increase in mean ABI-LoES rating after controlling for other variables. Admission MPAI-4 was negatively associated with mean ABI-LoES rating (ß=-0.07, t=-8.85, P<.0001). CONCLUSIONS: After controlling for nonmodifiable variables, average ABI-LoES rating is positively associated with outcome. Initial level of disability is negatively associated with mean ABI-LoES rating.

Patterns of Functional Change Five to Ten Years after Moderate-Severe Traumatic Brain Injury.

This study aims to characterize the patterns of functional change experienced between 5 and 10 years after moderate-severe traumatic brain injury (TBI). The study included TBI Model Systems national database participants (N = 372) at six sites who experienced TBI, received inpatient rehabilitation, and were followed at 5 and 10 years post-TBI. Outcome measures included self- or proxy-reported Functional Independence Measure (FIMTM) structured interview at 5 and 10 years post-TBI and domain change indices (DCIs) at 10 years to assess subjective change over the previous 5 years. When all seven FIM and subjective DCI subscales were considered together, 69% reported improvement in at least one subscale and 41% reported decline in at least one subscale; 51% reported more domains improved than declined, and 20% reported more domains declined than improved. Age at injury, post-traumatic amnesia duration, FIM, and depression and anxiety at year 5 were associated with FIM change and DCI measures. Although most persons with moderate-severe TBI do not experience widespread change from year 5 to 10 on individual FIM subscales or perceived domain-specific subscales, the vast majority do report change in one or more domains, with more improvement than decline and more change in subjective DCI than in FIM. Clinicians and researchers should be alert to the possibility of both positive and deleterious changes many years after TBI.

Response to the COVID-19 Pandemic Among Posthospital Brain Injury Rehabilitation Providers.

Rehabilitation after significant acquired brain injury (ABI) to address complex independent activities of daily living and return to family and community life is offered primarily after initial hospitalization in outpatient day treatment, group home, skilled nursing, and residential settings and in the home and community of the person served. The coronavirus 2019 pandemic threatened access to care and the health and safety of staff, persons served, and families in these settings. This article describes steps taken to contain this threat by 7 leading posthospital ABI rehabilitation organizations. Outpatient and day treatment facilities were temporarily suspended. In other settings, procedures for isolation, transportation, cleaning, exposure control, infection control, and use of personal protective equipment (PPE) were reinforced with staff. Visitation and community activities were restricted. Staff and others required to enter facilities were screened with symptom checklists and temperature checks. Individuals showing symptoms of infection were quarantined and tested, as possible. New admissions were carefully screened for infection and often initially quarantined. Telehealth played a major role in reducing direct interpersonal contact while continuing to provide services both to outpatients and within facilities. Salary, benefits, training, and managerial support were enhanced for staff. Despite early outbreaks, these procedures were generally effective, with preliminary initial infections rates of only 1.1% for persons served and 2.1% for staff. Reductions in admissions, services, and unanticipated expenses (eg, PPE, more frequent and thorough cleaning) had a major negative financial effect. Providers continue to be challenged to adapt rehabilitative approaches and to reopen services.

A Standard Method for Determining the Minimal Clinically Important Difference for Rehabilitation Measures.

The minimal clinically important difference (MCID) is receiving increasing interest and importance in medical practice and research. The MCID is the smallest improvement in scores in the domain of interest that patients perceive as beneficial. In clinical trials, comparing the proportion of individuals between treatment and control groups who obtain a MCID may be more informative than comparisons of mean change between groups because a statistically significant mean difference does not necessarily represent a difference that is perceived as meaningful by treatment recipients. The MCID may also be useful in advancing personalized medicine by characterizing those who are most likely to benefit from a treatment. In clinical practice, the MCID can be used to identify if a participant is experiencing a meaningful change in status. A variety of methods have been used to determine the MCID with no clear agreement on the most appropriate approach. Two major sets of methods are either (1) distribution-based, that is, referencing the MCID to a measure of variability or effect size in the measure of interest or (2) anchor-based, that is, referencing the MCID to an external assessment of change in the condition, ability, or activity represented by the measure of interest. In prior literature, using multiple methods to "triangulate" on the value of the MCID has been proposed. In this commentary, we describe a systematic approach to triangulate on the MCID using both distribution-based and anchor-based methods. Adaptation of a systematic approach for obtaining the MCID in rehabilitation would facilitate communication and comparison of results among rehabilitation researchers and providers.

Effectiveness of Post-Hospital Intensive Residential Rehabilitation after Acquired Brain Injury: Outcomes of 256 Program Completers Compared to Participants in a Residential Supported Living Program.

Post-hospital residential brain injury rehabilitation outcomes research is a complicated undertaking because of the custom-tailoring of interventions needed to meet the complex and unique need of each individual. As such, there tends to be great variability across program settings, which generally limits large-scale intervention studies. Growing literature demonstrates that post-hospital residential programs are beneficial. The main criticisms of this work include the absence of randomized-controlled studies, lack of clear definition of treatment types/settings, and small sample sizes. This study is a retrospective analysis of program evaluation data for a large, multi-site, national provider of post-hospital residential brain injury rehabilitation services. Specifically, outcome of participants completing Intensive Residential Rehabilitation (IRR) were compared to participants in the Residential Supported Living (RSL) program. Results demonstrate that participants in the IRR program improve and that participants in the RSL group preserve functional ability over time, suggesting that each program is effective in achieving its intended outcome. The IRR treatment group achieved significantly better outcomes than those in the same setting not receiving the intervention. To isolate treatment effects of IRR, a subsample of participants across program types were matched on time post-injury, age, and sex. The treatment effect of IRR was strengthened in this analysis, suggesting that chronicity alone does not account for the variance between the two groups.

Polytrauma Transitional Rehabilitation in the Veterans Administration: Implementing the Principles of Person-Centered, Participation-Oriented Rehabilitation.

OBJECTIVE: To review principles of person-centered, participation-oriented (PCPO) rehabilitation and introduce their implementation in Veterans Administration (VA) Polytrauma Transitional Rehabilitation Programs (PTRPs). BACKGROUND: Post-hospital rehabilitation for individuals with acquired brain injury (ABI) has evolved toward PCPO rehabilitation, an approach that makes participation goals identified by the person served and his or her significant others the primary focus of rehabilitation. Goals to reduce impairments and increase activities contribute to the achievement of primary participation goals. Research, primarily in the nonveteran population, confirms the effectiveness of PCPO rehabilitation. OVERVIEW: In the civilian sector, PCPO programs are generally provided locally or regionally in outpatient or community settings to individuals with moderate-severe ABI associated with other traumatic injuries and comorbidities. Because of the geographical dispersion of veterans, the VA provides these services in residential centers serving larger geographical areas. The group of veterans served more often has sustained milder traumatic ABI associated with neuropsychiatric comorbidities, particularly posttraumatic stress disorder and depression. Measuring progress and outcome is important to establish a feedback loop for process improvement. VA PTRPs use state-of-the-science standardized outcome measures and methods for identifying successful cases, that is, the minimal clinically important difference. Vocational reintegration is an important element of PCPO rehabilitation. Articles in this special section detail the development and effectiveness of PTRPs.

Evidence-Based Cognitive Rehabilitation: Systematic Review of the Literature From 2009 Through 2014.

OBJECTIVES: To conduct an updated, systematic review of the clinical literature, classify studies based on the strength of research design, and derive consensual, evidence-based clinical recommendations for cognitive rehabilitation of people with traumatic brain injury (TBI) or stroke. DATA SOURCES: Online PubMed and print journal searches identified citations for 250 articles published from 2009 through 2014. STUDY SELECTION: Selected for inclusion were 186 articles after initial screening. Fifty articles were initially excluded (24 focusing on patients without neurologic diagnoses, pediatric patients, or other patients with neurologic diagnoses, 10 noncognitive interventions, 13 descriptive protocols or studies, 3 nontreatment studies). Fifteen articles were excluded after complete review (1 other neurologic diagnosis, 2 nontreatment studies, 1 qualitative study, 4 descriptive articles, 7 secondary analyses). 121 studies were fully reviewed. DATA EXTRACTION: Articles were reviewed by the Cognitive Rehabilitation Task Force (CRTF) members according to specific criteria for study design and quality, and classified as providing class I, class II, or class III evidence. Articles were assigned to 1 of 6 possible categories (based on interventions for attention, vision and neglect, language and communication skills, memory, executive function, or comprehensive-integrated interventions). DATA SYNTHESIS: Of 121 studies, 41 were rated as class I, 3 as class Ia, 14 as class II, and 63 as class III. Recommendations were derived by CRTF consensus from the relative strengths of the evidence, based on the decision rules applied in prior reviews. CONCLUSIONS: CRTF has now evaluated 491 articles (109 class I or Ia, 68 class II, and 314 class III) and makes 29 recommendations for evidence-based practice of cognitive rehabilitation (9 Practice Standards, 9 Practice Guidelines, 11 Practice Options). Evidence supports Practice Standards for (1) attention deficits after TBI or stroke; (2) visual scanning for neglect after right-hemisphere stroke; (3) compensatory strategies for mild memory deficits; (4) language deficits after left-hemisphere stroke; (5) social-communication deficits after TBI; (6) metacognitive strategy training for deficits in executive functioning; and (7) comprehensive-holistic neuropsychological rehabilitation to reduce cognitive and functional disability after TBI or stroke.

Longitudinal Effects of Medical Comorbidities on Functional Outcome and Life Satisfaction After Traumatic Brain Injury: An Individual Growth Curve Analysis of NIDILRR Traumatic Brain Injury Model System Data.

OBJECTIVE: To explore associations of specific physical and neuropsychiatric medical conditions to motor and cognitive functioning and life satisfaction over the first 10 years following traumatic brain injury (TBI). SETTING: Telephone follow-up through 6 TBI Model System centers. PARTICIPANTS: In total, 404 individuals or proxies with TBI enrolled in the TBI Model System longitudinal study participating in 10-year follow-up. DESIGN: Individual growth curve analysis. MAIN MEASURES: FIM Motor and Cognitive subscales, Satisfaction With Life Scales, and Medical and Mental Health Comorbidities Interview. RESULTS: Hypertension, diabetes, cancers, rheumatoid arthritis, and anxiety negatively affected the trajectory of motor functioning over time. Diabetes, cancers, chronic bronchitis, anxiety, and depression negatively impacted cognitive functioning. Numerous neuropsychiatric conditions (sleep disorder, alcoholism, drug addiction, anxiety, panic attacks, posttraumatic stress disorder, depression, and bipolar disorder), as well as hypertension, liver disease, and cancers, diminished life satisfaction. Other medical conditions had a negative effect on functioning and satisfaction at specific follow-up periods. CONCLUSION: Natural recovery after TBI may include delayed onset of functional decline or early recovery, followed by progressive deterioration, and is negatively affected by medical comorbidities. Results contribute to the growing evidence that TBI is most appropriately treated as a chronic medical condition complicated by a variety of comorbid conditions.

Prevalence of Medical and Psychiatric Comorbidities Following Traumatic Brain Injury.

OBJECTIVE: To examine the prevalence of selected medical and psychiatric comorbidities that existed prior to or up to 10 years following traumatic brain injury (TBI) requiring acute rehabilitation. DESIGN: Retrospective cohort. SETTING: Six TBI Model Systems (TBIMS) centers. PARTICIPANTS: In total, 404 participants in the TBIMS National Database who experienced TBI 10 years prior. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Self-reported medical and psychiatric comorbidities and the onset time of each endorsed comorbidity. RESULTS: At 10 years postinjury, the most common comorbidities developing postinjury, in order, were back pain, depression, hypertension, anxiety, fractures, high blood cholesterol, sleep disorders, panic attacks, osteoarthritis, and diabetes. Comparing those 50 years and older to those younger than 50 years, diabetes (odds ratio [OR] = 3.54; P = .0016), high blood cholesterol (OR = 2.04; P = .0092), osteoarthritis (OR = 2.02; P = .0454), and hypertension (OR = 1.84; P = .0175) were significantly more prevalent in the older cohort while panic attacks (OR = 0.33; P = .0022) were significantly more prevalent in the younger cohort. No significant differences in prevalence rates between the older and younger cohorts were found for back pain, depression, anxiety, fractures, or sleep disorders. CONCLUSIONS: People with moderate-severe TBI experience other medical and mental health comorbidities during the long-term course of recovery and life after injury. The findings can inform further investigation into comorbidities associated with TBI and the role of medical care, surveillance, prevention, lifestyle, and healthy behaviors in potentially modifying their presence and/or prevalence over the life span.

Investigation of a New Couples Intervention for Individuals With Brain Injury: A Randomized Controlled Trial.

OBJECTIVES: This study aimed to (1) examine the efficacy of a treatment to enhance a couple's relationship after brain injury particularly in relationship satisfaction and communication; and (2) determine couples' satisfaction with this type of intervention. DESIGN: Randomized waitlist-controlled trial. SETTING: Midwestern outpatient brain injury rehabilitation center. PARTICIPANTS: Participants (N=44; 22 persons with brain injury and their intimate partners) were randomized by couples to the intervention or waitlist-controlled group, with 11 couples in each group. INTERVENTIONS: The Couples Caring and Relating with Empathy intervention is a 16-week, 2-hour, manualized small group treatment utilizing psychoeducation, affect recognition, empathy training, cognitive-behavioral and dialectical-behavioral strategies, communication skills training, and Gottman's theoretical framework for couples adjusted for individuals with brain injury. MAIN OUTCOME MEASURES: The Dyadic Adjustment Scale, Quality of Marriage Index (QMI), and the Four Horsemen of the Apocalypse communication questionnaire were implemented. Measures were completed by the person with brain injury and that person's partner at 3 time points: baseline, immediate postintervention, 3-month follow-up. RESULTS: The experimental group showed significant improvement at posttest and follow-up on the Dyadic Adjustment Scale and the Horsemen questionnaire compared to baseline and to the waitlist-controlled group which showed no significant changes on these measures. No significant effects were observed on the QMI for either group. Satisfaction scores were largely favorable. CONCLUSIONS: Results suggest this intervention can improve couples' dyadic adjustment and communication after brain injury. High satisfaction ratings suggest this small group intervention is feasible with couples following brain injury. Future directions for this intervention are discussed.

Social Competence Treatment After Traumatic Brain Injury: A Multicenter, Randomized Controlled Trial of Interactive Group Treatment Versus Noninteractive Treatment.

OBJECTIVE: To evaluate the effectiveness of a replicable group treatment program for improving social competence after traumatic brain injury (TBI). DESIGN: Multicenter randomized controlled trial comparing 2 methods of conducting a social competency skills program, an interactive group format versus a classroom lecture. SETTING: Community and veteran rehabilitation centers. PARTICIPANTS: Civilian, military, and veteran adults with TBI and social competence difficulties (N=179), at least 6 months postinjury. INTERVENTIONS: The experimental intervention consisted of 13 weekly group interactive sessions (1.5h) with structured and facilitated group interactions to improve social competence, and the control consisted of 13 traditional classroom sessions using the same curriculum with brief supplemental individual sessions but without structured group interaction. MAIN OUTCOME MEASURES: Profile of Pragmatic Impairment in Communication (PPIC), an objective behavioral rating of social communication impairments after TBI. LaTrobe Communication Questionnaire (LCQ), Goal Attainment Scale (GAS), Satisfaction with Life Scale, Posttraumatic Stress Disorder Checklist-C (PCL) civilian version, Brief Symptom Inventory 18 (BSI-18), Scale of Perceived Social Self-Efficacy (PSSE). RESULTS: Social competence goals (GAS) were achieved and maintained for most participants regardless of treatment method. Significant improvements in the primary outcome (PPIC) and 2 of the secondary outcomes (LCQ and BSI) were seen immediately posttreatment and at 3 months posttreatment in the alternative treatment arm only; however, these improvements were not significantly different between the group interactive structured treatment and alternative treatment arms. Similar trends were observed for PSSE and PCL-C. CONCLUSIONS: Social competence skills improved for persons with TBI in both treatment conditions. The group interactive format was not found to be a superior method of treatment delivery in this study.

Amantadine Did Not Positively Impact Cognition in Chronic Traumatic Brain Injury: A Multi-Site, Randomized, Controlled Trial.

Despite limited evidence to support the use of amantadine to enhance cognitive function after traumatic brain injury (TBI), the clinical use for this purpose is highly prevalent and is often based on inferred belief systems. The aim of this study was to assess effect of amantadine on cognition among individuals with a history of TBI and behavioral disturbance using a parallel-group, randomized, double-blind, placebo-controlled trial of amantadine 100 mg twice-daily versus placebo for 60 days. Included in the study were 119 individuals with two or more neuropsychological measures greater than 1 standard deviation below normative means from a larger study of 168 individuals with chronic TBI (>6 months post-injury) and irritability. Cognitive function was measured at treatment days 0, 28, and 60 with a battery of neuropsychological tests. Composite indices were generated: General Cognitive Index (included all measures), a Learning Memory Index (learning/memory measures), and Attention/Processing Speed Index (attention and executive function measures). Repeated-measures analysis of variance revealed statistically significant between-group differences favoring the placebo group at day 28 for General Cognitive Index (p = 0.002) and Learning Memory Index (p = 0.001), but not Attention/Processing Speed Index (p = 0.25), whereas no statistically significant between-group differences were found at day 60. There were no statistically significant between-group differences on adverse events. Cognitive function in individuals with chronic TBI is not improved by amantadine 100 mg twice-daily. In the first 28 days of use, amantadine may impede cognitive processing. However, the effect size was small and mean scores for both groups were generally within expectations for persons with history of complicated mild-to-severe TBI, suggesting that changes observed across assessments may not have functional significance. The use of amantadine to enhance cognitive function is not supported by these findings.