Clare Morey

A randomized trial of modafinil for the treatment of fatigue and excessive daytime sleepiness in individuals with chronic traumatic brain injury.

BackgroundThis study examines the efficacy of modafinil in treating fatigue and excessive daytime sleepiness in individuals with traumatic brain injury (TBI). MethodsA single-center, double-blind, placebo-controlled cross-over trial, where 53 participants with TBI were randomly assigned to receive up to 400 mg of modafinil, or equal number of inactive placebo tablets. Main eligibility criteria were being at least 1 year post-TBI severe enough to require inpatient rehabilitation. The primary outcome measures were fatigue (Fatigue Severity Scale, FSS) and daytime sleepiness (Epworth Sleepiness Scale, ESS). ResultsAfter adjusting for baseline scores and period effects, there were no statistically significant differences between improvements seen with modafinil and placebo in the FSS at week 4 (–0.5 ± 1.88; P = .80) or week 10 (–1.4 ± 2.75; P = .61). For ESS, average changes were significantly greater with modafinil than placebo at week 4 (–1.2 ± 0.49; P = .02) but not at week 10 (–0.5 ± 0.87; P = .56). Modafinil was safe and well tolerated, although insomnia was reported significantly more often with modafinil than placebo (P = .03). ConclusionsWhile there were sporadic statistically significant differences identified, a clear beneficial pattern from modafinil was not seen at either week 4 or week 10 for any of the 12 outcomes. There was no consistent and persistent clinically significant difference between treatment with modafinil and placebo.

Social communication skills in persons with post-acute traumatic brain injury: Three perspectives

Objective: To describe social communication skills problems identified by individuals with traumatic brain injury (TBI) compared to significant other (SO) and clinician ratings; and associations between these skills and participation outcome measures. Design: Cohort study. Methods: Sixty individuals with TBI ≥ 1 year post-injury were administered measures of social communication, societal participation, social integration and life satisfaction. Clinicians and SOs rated the social communication skills of the subjects. Results: Subjects were able to identify social communication skills problems, associated with lower ratings of community integration and satisfaction with life. Males reported higher scores in social communication and social integration than females. SOs and clinicians identified more social skills problems than subjects. Conclusions: Persons with TBI experience social communication skills deficits, associated with decreased societal participation and life satisfaction. Further research is needed to determine efficacy of social communication skills treatment and association with improved participation and satisfaction with life.

The effect of Aricept® in persons with persistent memory disorder following traumatic brain injury: a pilot study

Primary objective : To investigate the effectiveness of donepezil hydrochloride (Aricept®) in treating persistent memory deficits in people with traumatic brain injury. Research design : Single subject ABAC design was used so that each participant could serve as their own control. Methods and procedures : Seven TBI survivors with persistent memory dysfunction, at least 1.5 years post-injury, underwent two 6-month trials of Aricept®. The following tests were used to assess memory and cognition: Brief Visual Memory Test-Revised (BVMT-R), Hopkins Verbal Learning Test, Digit Span and Letter Number Sequence sub-test of the Wechsler Adult Intelligence Scale-III, Controlled Oral Word Association Test and Memory Functioning Questionnaire. Experimental intervention : During the first treatment phase, participants received 5 mg/day of Aricept® for 1 month, increasing to 10 mg/day of Aricept® for an additional 5 months. During the second treatment phase, participants received 5 mg/day of Aricept® for the entire 6 months. Main outcomes and results : A repeated measures analysis of variance indicated significant improvement on immediate and delayed memory portions of the BVMT-R when taking 10 mg/day of Aricept®. Conclusions : Findings contribute to the growing body of research into the use of Aricept® in treating memory deficits in TBI survivors and support the need for further research.

Social communication skills group treatment: A feasibility study for persons with traumatic brain injury and comorbid conditions

Objectives: To evaluate the feasibility of improving impaired social communication skills in persons with traumatic brain injury (TBI) and concomitant neurological or psychiatric conditions, using an intervention with evidence of efficacy in a TBI cohort without such complications. Research design: Cohort study with pre–post intervention and follow-up assessments. Methods: Thirty individuals with TBI ≥ 1 year post-injury and identified social communication problems participated in a group intervention to improve social communication skills. Interventions: Group Interactive Structured Treatment (GIST) for Social Competence; 13 week, 1.5 hour manualized intervention. Outcome measures: Profile of Pragmatic Impairment in Communication (PPIC); Social Communication Skills Questionnaire-Adapted (SCSQ-A); LaTrobe Communication Questionnaire (LCQ); Goal Attainment Scale (GAS), Awareness Questionnaire (AQ), Satisfaction with Life Scale (SWLS); Participation Assessment with Recombined Tools (PART). Main outcomes and results: Participants made statistically significant gains on the SCSQ-A, GAS and SWLS post-treatment and at 6 months follow-up, using self and other ratings. Gains on the PPIC did not reach statistical significance but trended toward improvement. Treatment effects were not noted in analyses of the AQ or the PART. The LCQ showed statistically significant gains post-treatment and at follow-up. Conclusions: Participants showed improvement on subjective social communication skills measures post-treatment and at follow-up, demonstrating potential efficacy of the intervention in a broader population of persons with TBI, worthy of further investigation.

Health and wellness characteristics of persons with traumatic brain injury

Objective: To describe health and wellness characteristics of persons with TBI living in the community, compare to other disability populations and evaluate the associations between health-related constructs. Design: Observational. Setting: Outpatient rehabilitation hospital and a Veterans Affairs Medical Centre. Participants: Seventy-four community-dwelling adults with moderate-to-severe TBI. Interventions: None. Main measures: Health Promoting Lifestyle Profile II (HPLP-II), Self Rated Abilities Health Practices Scale (SRAHP), Barriers to Health Promoting Activities for Disabled Scale (BHPAD), Medical Outcomes Study 12-Item Health Status Survey Short Form (SF-12), Personal Resource Questionnaire-adapted (PRQ-a), Perceived Wellness Survey (PWS), Diener Satisfaction with Life Scale (SWLS) and Participation Assessment with Recombined Tools–Objective (PART-O). Results: Health-promoting behaviours, self-efficacy and barriers to health were comparable to other disability populations. Perceived health status, participation and life satisfaction were decreased. Measures of health promotion and self-efficacy were positively associated with perceived mental health status, life satisfaction and participation. Barriers to healthy activities were negatively associated with health promotion, self-efficacy and perceived mental health status. Conclusions: Health and wellness status was below desired levels for the study cohort, and comparable to other disability populations. Better understanding of associations among health-related constructs is needed. Continued research on conceptually-based health and wellness interventions for persons with TBI is recommended.

Hypogonadism on admission to acute rehabilitation is correlated with lower functional status at admission and discharge

Primary objective: To investigate the association between hormone levels and functional status during acute TBI rehabilitation. Research design: Retrospective cohort study of 43 men with moderate-to-severe TBI admitted to an acute rehabilitation unit during a 1 year period. Methods and procedures: Labs were drawn on admission, including total and free testosterone (T), prolactin, adrenocorticotropin hormone (ACTH), cortisol, thyroid stimulating hormone (TSH), free thyroxine (fT4) and insulin-like growth factor (IGF-1). Functional Independence Measure (FIM) scores were obtained at admission and discharge. Main outcome and results: Associations between admission hormone levels and the main outcomes, admission and discharge FIM scores, were assessed using linear regression. Lower total and free T-levels at admission were associated with lower total FIM scores at admission (p < 0.038) and discharge (p < 0.046). Higher cortisol levels at admission were significantly associated with lower admission (p = 0.012) and discharge (p = 0.036) scores on the cognitive-FIM. Prolactin, TSH, fT4 and IGF-1 were not correlated with functional status. Conclusions: In men, lower total and free T-levels at admission to acute rehabilitation correlate with lower admission and discharge FIM scores. These data support the need for studies to investigate the impact of physiological testosterone therapy on outcomes during and post-rehabilitation.

Atomoxetine for attention deficits following traumatic brain injury: results from a randomized controlled trial.

Abstract Objective: To determine if atomoxetine would improve attention impairment following traumatic brain injury (TBI). Setting: Outpatients from a free-standing, private, not-for-profit rehabilitation hospital. Population: Fifty-five adult participants with a history of a single moderate-to-severe TBI, who were at least 1 year from injury and with self-reported complaints of attention difficulties. Intervention: Atomoxetine, a selective norepinephrine re-uptake inhibitor with a primary indication for attention dosed at 40 mg twice a day for 2 weeks, compared to placebo. Design: Randomized double-blind placebo controlled trial, with placebo run-in. Measures: Cognitive Drug Research (CDR), Computerized Cognitive Assessment System, Stroop Color and Word Test, Adult ADHD Self-Report Scale (ASRS-v1.1), Neurobehavioural Functioning Inventory (NFI). Results: Atomoxetine was well-tolerated by the subject sample. The use of atomoxetine by individuals with reported attention difficulty following TBI did not significantly improve scores on measures of attention, the CDR Power of Attention domain or the Stroop Interference score. In addition, no significant relationship was found between atomoxetine use and self-reported symptoms of attention or depression. Conclusion: Atomoxetine did not significantly improve performance on measures of attention among individuals post-TBI with difficulties with attention. This study follows a trend of other pharmacological studies not demonstrating significant results among those with a history of TBI. Various possibilities are discussed, including the need for a more sophisticated system of classification of TBI. Trial registration: ClinicalTrials.gov identifier: NCT00702364.

A health and wellness intervention for those with moderate to severe traumatic brain injury: a randomized controlled trial.

Objectives:To assess the efficacy of a standardized 12-week health and wellness group intervention for those with moderate to severe traumatic brain injury (TBI). Study Design:Randomized controlled trial. Participants:Seventy-four individuals with moderate to severe TBI recruited from the outpatient program at a rehabilitation hospital, a Veterans Affairs Medical Center, and the community. Method:Eligible participants were randomized to treatment (health and wellness therapy group) or wait-list control (treatment, n = 37; wait-list, n = 37). The primary outcome was the Health Promoting Lifestyle Profile-II. Results:The results of the mixed-model repeated-measures analysis indicated no differences between treatment and control groups engaging in activities to increase their health and well-being. Conclusions:Findings did not support the efficacy of the intervention. Results may have been impacted by the wide variability of individualized health and wellness goals selected by group members, the structure and/or content of the group, and/or the outcome measures selected.

Improving personal self-advocacy skills for individuals with brain injury: A randomized pilot feasibility study.

ABSTRACT Objective: To investigate the feasibility of a self-advocacy intervention for individuals with acquired brain injury (ABI). Design: Two-arm, parallel-design, randomized feasibility study. Methods: Twelve participants, 1-year or more post-ABI (TBI and cerebral vascular accident (CVA)), were randomized into treatment/control groups. The treatment group received a group intervention and workbook; the control group received the workbook only. Outcome measures, taken at baseline, post-treatment and 6-weeks follow-up, included the General Self-Efficacy Scale (GSES), Satisfaction with Life Scale (SWLS) and Goal Attainment Scale (GAS) and two exploratory measures developed for the study: the Self Advocacy Scale (SAS) and the Personal Advocacy Activity Scale (PAAS). Results: Participants were successfully recruited and treated per protocol. The treatment group exhibited improvements from baseline to post-treatment on all measures; the control group improved on the GSES and declined on all others. Both groups exhibited improvement on all measures at follow-up, except the PAAS, which declined. There were no significant group differences on non-parametric analysis at any assessment points; however, the magnitude of change at post-treatment approached significance for the SAS and PAAS. Conclusions: Initial feasibility for the methodology was demonstrated. Positive trends were noted. Further research could result in an evidence-based intervention to enhance self-advocacy post-ABI.

Cannabis Use in Individuals With Spinal Cord Injury or Moderate to Severe Traumatic Brain Injury in Colorado

OBJECTIVES To describe the prevalence of cannabis use in an adult sample with spinal cord injury (SCI) or traumatic brain injury (TBI) in Colorado, and to describe the self-reported reasons and side effects of cannabis use in this sample. DESIGN Mixed-methods observational study, using focus group data and telephone survey. SETTING Community. PARTICIPANTS Colorado adults who sustained SCI or moderate to severe TBI and received services through Craig Hospital. INTERVENTIONS None. MAIN OUTCOME MEASURES Survey. RESULTS Focus group participants identified issues that were then included in the survey development. Seventy percent of the 116 participants surveyed reported cannabis use before their injury (67% SCI, 74% TBI) and 48% reported use after their injury (53% SCI, 45% TBI). Overall, the most common reason for use was recreational (67%), followed by reducing stress/anxiety (62.5%) and improving sleep (59%). Among the respondents with SCI, the most common reasons for use were to reduce spasticity (70%), recreation (63%), and to improve sleep (63%). Among those with TBI, reasons endorsed were recreational (72%), reducing stress/anxiety (62%), and improving sleep (55%). Smoking was the most common method of use. CONCLUSIONS A majority of this sample reported using cannabis before injury, and approximately half reported using cannabis after injury. Both groups reported recreational use, whereas the group with SCI also highly endorsed using cannabis to address chronic medical conditions. Clinicians should be aware of the high prevalence of cannabis use in these populations and the impact such use may have on the individuals medical management. Further research in this area is needed.