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1.
Rehabil Psychol ; 67(2): 235-240, 2022 May.
Article in English | MEDLINE | ID: mdl-35377697

ABSTRACT

PURPOSE/OBJECTIVE: Health disparities in rehabilitation have been identified in brain injury (BI), spinal cord injury (SCI), stroke, and amputee populations. A free clinic was established to serve such uninsured individuals. The purpose of this exploratory study was to characterize the sample of patients attending a free rehabilitation clinic by investigating their demographics, access to care, trends in quality of life, and satisfaction with the rehabilitation program. METHOD/DESIGN: This is a retrospective chart review of data from 15 individuals admitted to the free clinic program who were administered an admission questionnaire, the abbreviated World Health Organization Quality of Life assessment (WHOQOL-BREF), and a postcare assessment survey. RESULTS: A majority of patients reported not having a primary care provider nor a checkup within the past 5 years. This sample also reported extensive physical needs at admission. Seventy-three percent of the sample improved on the WHOQOL-BREF physical domain by discharge with a large effect size. The psychological, social, and environmental domain scores did not show a reliable pattern of change in this sample. Conclusions/Implication: These results support previously noted gaps in care among individuals with BI, SCI, stroke, and amputation and suggest that a monthly clinic can improve physical quality of life. This exploratory study aims to lay the foundation for future research that is needed to understand the factors that exclude these individuals from the health care system and to help key stakeholders to advocate for these patients and improve their early access to rehabilitation care. (PsycInfo Database Record (c) 2022 APA, all rights reserved).


Subject(s)
Spinal Cord Injuries , Stroke , Humans , Medically Uninsured , Quality of Life/psychology , Retrospective Studies , Spinal Cord Injuries/rehabilitation , Surveys and Questionnaires
2.
NeuroRehabilitation ; 46(3): 355-368, 2020.
Article in English | MEDLINE | ID: mdl-32250330

ABSTRACT

BACKGROUND: Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function. OBJECTIVE: Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation. DESIGN: Randomized, double blind, placebo-controlled pilot trial. SETTING: Inpatient rehabilitation brain injury unit. PARTICIPANTS: Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation. INTERVENTIONS: Transdermal T gel or placebo. MAIN OUTCOME MEASURES: Revised FIM™ score, strength, adverse events. RESULTS: Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into placebo (n = 10) or physiologic T therapy (n = 12). There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, or slopes t = 0.61, p = 0.5472). The Treatment group demonstrated the greatest absolute improvement in FIM™ scores and grip strength compared to Placebo or Normal T groups. There was no difference in adverse events between groups. Percentage of time with agitation or aggression was highest in the Placebo group. CONCLUSIONS: Although there were no significant differences in rates of recovery, treatment group subjects showed greater absolute functional and strength improvement compared to the Placebo or Normal T groups.


Subject(s)
Androgens , Brain Injuries, Traumatic , Eunuchism , Testosterone , Adolescent , Adult , Aged , Androgens/administration & dosage , Androgens/adverse effects , Androgens/therapeutic use , Brain Injuries, Traumatic/complications , Brain Injuries, Traumatic/physiopathology , Brain Injuries, Traumatic/rehabilitation , Double-Blind Method , Eunuchism/drug therapy , Eunuchism/etiology , Humans , Male , Middle Aged , Recovery of Function , Testosterone/administration & dosage , Testosterone/adverse effects , Testosterone/therapeutic use , Young Adult
3.
Am J Occup Ther ; 74(1): 7401185050p1-7401185050p7, 2020.
Article in English | MEDLINE | ID: mdl-32078510

ABSTRACT

IMPORTANCE: Vision impairments are common after traumatic brain injury (TBI). Little evidence exists to assist clinicians with effective interventions for impaired oculomotor skills in people with TBI. OBJECTIVE: To pilot a randomized controlled trial (RCT) of oculomotor treatment in TBI rehabilitation. DESIGN: An impairment-based oculomotor protocol was compared with an activity-based standard of care in a two-group RCT. Participants were masked to assignment. SETTING: Inpatient rehabilitation. PARTICIPANTS: For 1 yr, 138 people with TBI, ages 18-65 yr, were screened. Twenty-six were eligible; 6 declined. Inclusion criteria: oculomotor impairment. Exclusion criteria: inpatient stay <6 wk, blind, no functional arm use, unable to follow a three-step command, attention <30 min, or in another clinical trial. INTERVENTION: Participants were randomized into an experimental group (n = 10) receiving the Six Eye Exercises protocol or a control group (n = 10) receiving a standard-of-care protocol for 30 min/day, 5 days/wk, for 4 wk. Oculomotor and related functional impairments were measured at baseline and posttreatment. OUTCOMES AND MEASURES: Measures were chosen before the start. Primary outcome measure: Craig Hospital Eye Evaluation Rating Scale for oculomotor status. Secondary measures for functional status: King-Devick Test, Delis-Kaplan Executive Function System Trail Making Test: Condition 1 Visual Scanning, Modified Nelson-Denny Reading Test, and Subjective Vision Symptom Scale. RESULTS: Sixteen participants finished. Fatigue was the primary reason for withdrawal. No other negative effects were noted. Selected outcome measures captured positive improvements in both groups. CONCLUSIONS AND RELEVANCE: Study findings suggest conducting an appropriately powered RCT to evaluate efficacy of oculomotor treatment in this population. WHAT THIS ARTICLE ADDS: Oculomotor dysfunction seems to improve during inpatient TBI rehabilitation with remedial treatment. Best practice in occupational therapy has not yet been established. An appropriately powered RCT could positively contribute to the evidence available to clinicians.


Subject(s)
Brain Injuries, Traumatic , Occupational Therapy , Adolescent , Adult , Aged , Brain Injuries, Traumatic/physiopathology , Eye Movements/physiology , Humans , Middle Aged , Pilot Projects , Young Adult
4.
Neurorehabil Neural Repair ; 34(2): 111-121, 2020 02.
Article in English | MEDLINE | ID: mdl-31884895

ABSTRACT

Background. Disrupted sleep is common after traumatic brain injury (TBI) particularly in the inpatient rehabilitation setting where it may affect participation in therapy and outcomes. Treatment of sleep disruption in this setting is varied and largely unexamined. Objective. To study the feasibility of instituting a sleep hygiene intervention on a rehabilitation unit. Methods. Twenty-two individuals admitted to a brain injury unit were enrolled and allocated, using minimization, to either a sleep hygiene protocol (SHP) or standard of care (SOC). All participants wore actigraphs, underwent serial cognitive testing, and had light monitors placed in their hospital rooms for 4 weeks. Additionally, participants in the SHP received 30 minutes of blue-light therapy each morning, had restricted caffeine intake after noon, and were limited to 30-minute naps during the day. SHP participants had their lights out time set according to preinjury sleep time preference. Both groups were treated with the same restricted formulary of centrally acting medications. Results. Of 258 patients screened, 27 met all study inclusion criteria of whom 22 were enrolled. Nine participants in each group who had at least 21 days of treatment were retained for analysis. The protocol was rated favorably by participants, families, and staff. Actigraph sleep metrics improved in both groups during the 4-week intervention; however, only in the SHP was the change significant. Conclusions. Sleep hygiene is a feasible, nonpharmacologic intervention to treat disrupted sleep in a TBI inpatient rehabilitation setting. A larger study is warranted to examine treatment efficacy. ClinicalTrials.gov Identifier: NCT02838082.


Subject(s)
Brain Injuries, Traumatic/rehabilitation , Neurological Rehabilitation , Outcome and Process Assessment, Health Care , Sleep Hygiene , Sleep Wake Disorders/rehabilitation , Actigraphy , Adult , Brain Injuries, Traumatic/complications , Feasibility Studies , Female , Humans , Male , Middle Aged , Patient Satisfaction , Phototherapy , Pilot Projects , Severity of Illness Index , Sleep Disorders, Circadian Rhythm/etiology , Sleep Disorders, Circadian Rhythm/rehabilitation , Sleep Hygiene/physiology , Sleep Wake Disorders/etiology , Young Adult
5.
Brain Inj ; 33(9): 1194-1199, 2019.
Article in English | MEDLINE | ID: mdl-31215813

ABSTRACT

Objective: Disrupted sleep is common during acute recovery from traumatic brain injury (TBI) and has been linked to daytime agitation. This study investigated the relationship among nighttime sleep efficiency (SE), total sleep time (TST), wakefulness after sleep onset (WASO), and number of wake bouts (NWB) as measured by actigraphy to observer ratings of agitation for patients with TBI who were undergoing inpatient rehabilitation. Methods: This is a retrospective, observational study of a convenience sample of 65 individuals admitted to TBI inpatient rehabilitation who were monitored with actigraphy and the Agitated Behaviour Scale (ABS) for the first 72 h. Each patient's average SE, TST, WASO, and NWB for the 72-h period was calculated using actigraphy for the rest interval from 2100 to 0700. Daily ABS scores were obtained for each day following the nighttime sleep period. Results: Patients were not significantly different on age, gender, etiology of injury, days post-injury, rehabilitation length of stay, or severity of injury as measured by length of posttraumatic amnesia (PTA). SE and TST were significantly lower for patients with agitation than for patients without agitation. Conclusions: This study suggests a relationship between disrupted sleep and agitation for patients with TBI who are undergoing inpatient rehabilitation.


Subject(s)
Brain Injuries, Traumatic/complications , Psychomotor Agitation/etiology , Sleep Wake Disorders/etiology , Actigraphy , Adult , Aged , Amnesia/etiology , Amnesia/psychology , Brain Injuries, Traumatic/rehabilitation , Female , Humans , Injury Severity Score , Length of Stay , Male , Middle Aged , Predictive Value of Tests , Retrospective Studies , Treatment Outcome , Wakefulness , Young Adult
6.
Brain Inj ; 32(8): 980-985, 2018.
Article in English | MEDLINE | ID: mdl-29708442

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.


Subject(s)
Brain Injuries, Traumatic/psychology , Emotions/physiology , Employment , Personal Satisfaction , Residence Characteristics , Adult , Brain Injuries, Traumatic/complications , Brain Injuries, Traumatic/rehabilitation , Cognition Disorders/etiology , Cohort Studies , Female , Humans , Male , Middle Aged , Neuropsychological Tests , Randomized Controlled Trials as Topic , Self Report , Spinal Cord Injuries/psychology , Spinal Cord Injuries/rehabilitation , Surveys and Questionnaires
7.
Artif Organs ; 41(11): E196-E202, 2017 Nov.
Article in English | MEDLINE | ID: mdl-29148128

ABSTRACT

Spinal cord injury (SCI) often results in loss of upright mobility and independence subsequently challenging rehabilitation practitioners for meaningful intervention strategies. The objective of this study was to evaluate the feasibility and potential impact on walking function of the stimulation and ergometer training protocol (STEP) in chronic SCI. Fourteen individuals with a chronic motor incomplete SCI (>1-year post injury) were enrolled in the study. The intervention consisted of a 12-week walking training program delivered three times per week from 20 up to 45 min in combination with 10 channels of FES on a step ergometer. Subsequent to this training, 30 min over ground walking training was performed. Ten out of the 14 participants completed the trial (71%). All participants who completed the intervention increased their walking speed by an average of 0.13 m/s (0.08) and walking endurance by an average of 117 ft (84 ft). For those who completed the trial, 50% demonstrated increases on the Walking Index for Spinal Cord Injury II by at least one level while 60% demonstrated an increase in lower extremity motor scores; all completing the Timed Up and Go Test at baseline demonstrated a reduction in time to complete during post-test evaluation. Recruitment objectives were attained. Overall retention was lower than anticipated with 29% withdrawing secondary to issues with lower extremity pain and exertional demands; however, no other adverse events occurred. Improvements in mobility outcomes generated by the STEP show promise in the context of feasibility and warrant further investigation to evaluate efficacy in comparison to other walking recovery interventions. The STEP was well-tolerated by participants who were >1 year and less than 10 years post SCI. Those completing the protocol exhibited improvements in commonly used SCI walking outcome measures.


Subject(s)
Electric Stimulation Therapy/methods , Ergometry/methods , Lower Extremity/innervation , Motor Activity , Spinal Cord Injuries/rehabilitation , Walking , Adult , Aged , Electric Stimulation Therapy/instrumentation , Equipment Design , Ergometry/instrumentation , Exercise Test , Exercise Tolerance , Feasibility Studies , Female , Gait , Humans , Male , Middle Aged , Recovery of Function , Spinal Cord Injuries/diagnosis , Spinal Cord Injuries/physiopathology , Time Factors , Treatment Outcome , Young Adult
8.
Brain Inj ; 31(3): 290-296, 2017.
Article in English | MEDLINE | ID: mdl-28095051

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.


Subject(s)
Brain Injuries , Personal Satisfaction , Personality , Self Efficacy , Adult , Brain Injuries/complications , Brain Injuries/psychology , Brain Injuries/rehabilitation , Feasibility Studies , Female , Follow-Up Studies , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Pilot Projects , Surveys and Questionnaires , Young Adult
9.
NeuroRehabilitation ; 35(3): 467-73, 2014.
Article in English | MEDLINE | ID: mdl-25227544

ABSTRACT

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 group's 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).


Subject(s)
Brain Injuries/rehabilitation , Stroke Rehabilitation , Wheelchairs , Activities of Daily Living , Adult , Brain Injuries/complications , Cranial Fossa, Posterior/anatomy & histology , Cross-Over Studies , Equipment Design , Female , Humans , Male , Middle Aged , Paresis/etiology , Paresis/rehabilitation , Personal Autonomy , Psychomotor Performance , Range of Motion, Articular , Stroke/complications , Treatment Outcome , Young Adult
10.
Brain Inj ; 28(12): 1514-22, 2014.
Article in English | MEDLINE | ID: mdl-25180876

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.


Subject(s)
Adrenergic Uptake Inhibitors/therapeutic use , Attention Deficit Disorder with Hyperactivity/etiology , Brain Injuries/complications , Executive Function/drug effects , Propylamines/therapeutic use , Atomoxetine Hydrochloride , Attention Deficit Disorder with Hyperactivity/drug therapy , Attention Deficit Disorder with Hyperactivity/physiopathology , Brain Injuries/drug therapy , Brain Injuries/physiopathology , Cross-Over Studies , Double-Blind Method , Female , Glasgow Coma Scale , Humans , Male , Recovery of Function , Severity of Illness Index , Treatment Outcome
12.
Brain Inj ; 28(2): 181-8, 2014.
Article in English | MEDLINE | ID: mdl-24456057

ABSTRACT

OBJECTIVE: To evaluate the feasibility and safety of utilizing a commercially available virtual reality gaming system as a treatment intervention for balance training. DESIGN: A randomized controlled trial in which assessment and analysis were blinded. SETTING: An inpatient rehabilitation facility. INTERVENTION: Interventions included balance-based physical therapy using a Nintendo Wii, as monitored by a physical therapist, and receipt of one-on-one balance-based physical therapy using standard physical therapy modalities available for use in the therapy gym. RESULTS: Participants in the standard physical therapy group were found to have slightly higher enjoyment at mid-intervention, while those receiving the virtual reality-based balance intervention were found to have higher enjoyment at study completion. Both groups demonstrated improved static and dynamic balance over the course of the study, with no significant differences between groups. Correlational analyses suggest a relationship exists between Wii balance board game scores and BBS scores for measures taken beyond the baseline assessment. CONCLUSIONS: This study provides a modest level of evidence to support using commercially available VR gaming systems for the treatment of balance deficits in patients with a primary diagnosis of TBI receiving inpatient rehabilitation. Additional research of these types of interventions for the treatment of balance deficits is warranted.


Subject(s)
Brain Injuries/rehabilitation , Exercise Therapy , Physical Therapy Modalities , Postural Balance , Virtual Reality Exposure Therapy , Adult , Brain Injuries/physiopathology , Brain Injuries/therapy , Female , Humans , Inpatients , Male , Middle Aged , Pilot Projects , Program Evaluation , Single-Blind Method , Treatment Outcome , Video Games , Virtual Reality Exposure Therapy/methods
13.
Brain Inj ; 24(11): 1298-310, 2010.
Article in English | MEDLINE | ID: mdl-20828228

ABSTRACT

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.


Subject(s)
Brain Injuries/rehabilitation , Communication Disorders/rehabilitation , Quality of Life/psychology , Adolescent , Adult , Aged , Brain Injuries/physiopathology , Brain Injuries/psychology , Cohort Studies , Communication , Communication Disorders/physiopathology , Communication Disorders/psychology , Feasibility Studies , Female , Humans , Male , Middle Aged , Neuropsychological Tests , Patient Satisfaction/statistics & numerical data , Social Adjustment , Social Behavior , Surveys and Questionnaires , Treatment Outcome , Young Adult
14.
J Head Trauma Rehabil ; 23(1): 52-63, 2008.
Article in English | MEDLINE | ID: mdl-18219235

ABSTRACT

BACKGROUND: This study examines the efficacy of modafinil in treating fatigue and excessive daytime sleepiness in individuals with traumatic brain injury (TBI). METHODS: A 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). RESULTS: After 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). CONCLUSIONS: While 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.


Subject(s)
Benzhydryl Compounds/administration & dosage , Brain Injuries/complications , Central Nervous System Stimulants/administration & dosage , Fatigue/drug therapy , Adult , Chronic Disease , Double-Blind Method , Fatigue/etiology , Female , Humans , Injury Severity Score , Male , Middle Aged , Modafinil , Sleep Disorders, Circadian Rhythm , Treatment Outcome
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