Don Gerber

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 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.

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.

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.

Psychological well-being in individuals living in the community with traumatic brain injury

ABSTRACT Background: Well-being and quality of life issues remain a long-term problem for many individuals with traumatic brain injury (TBI). Meaningful activity is key to developing life satisfaction and a sense of contribution to society, yet individuals with TBI are often unable to return to competitive employment. Objective: To describe the self-reported psychological well-being of a cohort of unemployed individuals living in the community at least 1 year post TBI with low life satisfaction. Methods: Seventy-four unemployed individuals with low life satisfaction at least 1 year post TBI were administered measures of psychological well-being and cognitive functioning. Results: This cohort of 74 participants demonstrated cognitive impairment and elevated levels of emotional distress. Significant bivariate relationships were noted among nearly all measures of well-being, and associations were in the directions as expected. Individuals reported low life satisfaction and well-being. Two newer measures of well-being correlated with established measures used with this population. Conclusions: Individuals with TBI living in the community who are not employed but who seek to be productive reported low life satisfaction and well-being. This study highlights the need for interventions aimed at increasing productivity and meaning in life for individuals with TBI, and a broader understanding of psychological health after TBI.

Natural History of Neuroendocrine Dysfunction after Traumatic Brain Injury during Inpatient Rehabilitation

Disclosures: M. E. Wierman, No Answer Objective: To assess changes in hormone function in men undergoing acute rehabilitation after TBI. Design: Prospective evaluation of the gonadal, adrenal, thyroid and growth hormone axes inmenwith normal and low testosterone (T) levels. Setting: Inpatient brain injury unit in a private, not-for-profit rehabilitation hospital in the United States. Participants: Men ages 18 e 65 enrolled in inpatient rehabilitation following moderate to severe TBI,within 6months from thedate of injury. Interventions: Not applicable. Main Outcome Measures: Serum hormones at baseline and every 2 weeks until discharge. Results or Clinical Course: 498 patients were screened, for a final N of 61. 38 subjects had normal T, 23 had low T levels (<260ng/dl). At baseline, LH, FSH, T, estradiol (E), SHBG prolactin, TSH, fT4, ACTH, cortisol, DHEAS and, IGF1 levels were measured. Men with low T demonstrated lower LH levels (P1⁄4.003) and a trend towards lower FSH levels than those with normal T, suggesting that hypogonadism was related to central dysfunction. TSH was also lower (P1⁄4.035) in subjects with low testosterone. Hormone levels in those with normal T remained stable. In those with low T, only 50% normalized their T levels by 4-8 wks. Other hormone deficits were infrequent and transitory. Conclusion: After TBI, men with hypogonadism had lower gonadotropin and TSH levels suggesting central dysfunction. Testosterone levels remained low in 50% of subjects with low T at 4-8 wks. Associated neuroendocrine dysfunction was transient. These data suggest that hypogonadism detected during acute rehabilitation often does not resolve without intervention. Monitoring for hormonal deficits is appropriate. Future studies are needed to determine if T replacement modulates functional or cognitive outcomes after TBI.

Comment on The Decision to Provide Testosterone Supplementation to Patients With Traumatic Brain Injury

To the Editor, We read with interest the article, “The Decision to Provide Testosterone Supplementation in Patients With Traumatic Brain Injury,” [1] published in the November issue of this journal. In this article, warning is expressed by the authors that “an acute change in mental status including but not limited to aggressiveness, motor restlessness, cognitive decline, and paranoia after beginning steroid supplementation should alert the clinician to a hormonal cause of the mental status change,” suggesting that it is their belief that the patient’s increased agitation was definitively linked to testosterone supplementation. The incidence of hypogonadism in men after severe traumatic brain injury is approximately 30% [2]. We have been conducting a prospective, placebo-controlled clinical trial of testosterone (T) therapy for men who exhibit hypogonadism (low testosterone, defined as a serum T <260 ng/dL) after traumatic brain injury. To date we have had only 1 adverse event related to aggressive behavior from among 36 participants, and that individual was in the normal testosterone control group (ie, individuals with normal testosterone who are not receiving any treatment or placebo). As serum assessment of the patient’s endocrine status in the case report was not performed during the period of agitation, there is no way to know what the underlying mechanism of this patient’s agitation was, or whether it was related to his hormone status at all. It appears that the patient’s T level was normal at the time of initiation of T therapy, which would suggest that he was not hypogonadal. Although we acknowledge that testosterone therapy, if given to men who are not hypogonadal, or in high doses, can be associated with adverse events [3], we disagree that physiologic T therapy to correct hypogonadal men to normal T levels would do so. We agree with the authors that a careful risk-benefit analysis should be performed before initiation of testosterone therapy, but we caution against the generalization of their conclusions to indicate that testosterone supplementation is contraindicated in all patients with TBI.

Two approaches to manual wheelchair configuration and effects on function for individuals with acquired brain injury

OBJECTIVE To determine whether manual wheelchair configuration impacts how well a person who has acquired brain injury (ABI) related hemiparesis performs functional tasks from his or her wheelchair. DESIGN Multi-treatment cross-over design. SETTING Inpatient rehabilitation hospital. PARTICIPANTS Nineteen patients with ABI resulting in hemiparesis undergoing inpatient rehabilitation (average of 75 days post-injury (± 29.2 days); age range, 21-64; 9 with mechanical brain injury, 10 with cerebral vascular accident). INTERVENTIONS Participants in the study were placed in two different wheelchair configurations (position one and position two) and were randomized as to which position they were placed in first. All outcome measures were taken twice on each individual within each wheelchair configuration during two consecutive days. MAIN OUTCOME MEASURES Timed Forward Wheeling (TFW), Modified Functional Reach test (MFR), Visual Analogue Scale for Comfort (VAS), transfer score from the Functional Independence Measure (FIM), measurement of popliteal fossa to front of cushion. RESULTS The position two seating groups TFW was significantly faster than the position one seating group at both time points. There were no significant differences in the MFR scores, VAS comfort scale scores, and FIM transfer score between the two groups. CONCLUSION A wheelchair configuration with no seat slope, solid backrest mounted at 95 degree (± 3 degrees) seat to back angle, and use of a solid seat insert with a flat foam cushion (position two) results in greater efficiency in foot propulsion for individuals with ABI than a wheelchair configuration with one inch of seat slope, solid backrest mounted at 105 degree (± 3 degrees) seat to back angle, and no solid seat insert with a gel/foam contoured cushion (position 1).