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1.
Arch Phys Med Rehabil ; 104(4): 619-630, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36632965

RESUMEN

OBJECTIVE: To examine the prevalence, severity, and correlates of depression, anxiety, and suicidal ideation in people with traumatic brain injury (TBI) assessed before and during the COVID-19 pandemic. DESIGN: Retrospective cohort study using data collected through the Traumatic Brain Injury Model Systems (TBIMS) network at 1, 2, 5, 10, 15, 20, 25, or 30 years post TBI. SETTING: United States-based TBIMS rehabilitation centers with telephone assessment of community residing participants. PARTICIPANTS: Adults (72.4% male; mean age, 47.2 years) who enrolled in the TBIMS National Database and completed mental health questionnaires prepandemic (January 1, 2017 to February 29, 2020; n=5000) or during pandemic (April 1, 2022 to June 30, 2021; n=2009) (N=7009). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 questionnaire. RESULTS: Separate linear and logistic regressions were constructed with demographic, psychosocial, injury-related, and functional characteristics, along with a binary indicator of COVID-19 pandemic period (prepandemic vs during pandemic), as predictors of mental health outcomes. No meaningful differences in depression, anxiety, or suicidal ideation were observed before vs during the COVID-19 pandemic. Correlations between predictors and mental health outcomes were similar before and during the pandemic. CONCLUSIONS: Contrary to our predictions, the prevalence, severity, and correlates of mental health conditions were similar before and during the COVID-19 pandemic. Results may reflect generalized resilience and are consistent with the most recent findings from the general population that indicate only small, transient increases in psychological distress associated with the pandemic. While unworsened, depression, anxiety, and suicidal ideation remain prevalent and merit focused treatment and research efforts.


Asunto(s)
Lesiones Traumáticas del Encéfalo , COVID-19 , Suicidio , Adulto , Humanos , Masculino , Estados Unidos/epidemiología , Persona de Mediana Edad , Femenino , Ideación Suicida , Pandemias , Depresión/epidemiología , Estudios Retrospectivos , Vida Independiente , Investigación en Rehabilitación , COVID-19/epidemiología , Lesiones Traumáticas del Encéfalo/rehabilitación , Ansiedad/epidemiología , Trastornos de Ansiedad/epidemiología
2.
Arch Phys Med Rehabil ; 104(7): 1041-1053, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-36736808

RESUMEN

OBJECTIVE: To examine the effect of the COVID-19 pandemic on societal participation in people with moderate-to-severe traumatic brain injury (TBI). DESIGN: Cross-sectional retrospective cohort. SETTING: National TBI Model Systems centers, United States. PARTICIPANTS: TBI Model Systems enrollees (N=7003), ages 16 and older and 1-30 years postinjury, interviewed either prepandemic (PP) or during the pandemic (DP). The sample was primarily male (72.4%) and White (69.5%), with motor vehicle collisions as the most common cause of injury (55.1%). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The 3 subscales of the Participation Assessment with Recombined Tools-Objective: Out and About (community involvement), Productivity, and Social Relations. RESULTS: Out and About, but not Productivity or Social Relations, scores were appreciably lower among DP participants compared to PP participants (medium effect). Demographic and clinical characteristics showed similar patterns of association with participation domains across PP and DP. When their unique contributions were examined in regression models, age, self-identified race, education level, employment status, marital status, income level, disability severity, and life satisfaction were variably predictive of participation domains, though most effects were small or medium in size. Depression and anxiety symptom severities each showed small zero-order correlations with participation domains across PP and DP but had negligible effects in regression analyses. CONCLUSIONS: Consistent with the effect of COVID-19 on participation levels in the general population, people with TBI reported less community involvement during the pandemic, potentially compounding existing postinjury challenges to societal integration. The pandemic does not appear to have altered patterns of association between demographic/clinical characteristics and participation. Assessing and addressing barriers to community involvement should be a priority for TBI treatment providers. Longitudinal studies of TBI that consider pandemic-related effects on participation and other societally linked outcomes will help to elucidate the potential longer-term effect the pandemic has on behavioral health in this population.


Asunto(s)
Lesiones Traumáticas del Encéfalo , COVID-19 , Humanos , Masculino , Estados Unidos/epidemiología , Pandemias , Estudios Retrospectivos , Estudios Transversales , COVID-19/epidemiología , COVID-19/complicaciones , Lesiones Traumáticas del Encéfalo/epidemiología , Lesiones Traumáticas del Encéfalo/complicaciones
3.
Arch Phys Med Rehabil ; 101(6): 1072-1089, 2020 06.
Artículo en Inglés | MEDLINE | ID: mdl-32087109

RESUMEN

Persons who have disorders of consciousness (DoC) require care from multidisciplinary teams with specialized training and expertise in management of the complex needs of this clinical population. The recent promulgation of practice guidelines for patients with prolonged DoC by the American Academy of Neurology, American Congress of Rehabilitation Medicine (ACRM), and National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) represents a major advance in the development of care standards in this area of brain injury rehabilitation. Implementation of these practice guidelines requires explication of the minimum competencies of clinical programs providing services to persons who have DoC. The Brain Injury Interdisciplinary Special Interest Group of the ACRM, in collaboration with the Disorders of Consciousness Special Interest Group of the NIDILRR-Traumatic Brain Injury Model Systems convened a multidisciplinary panel of experts to address this need through the present position statement. Content area-specific workgroups reviewed relevant peer-reviewed literature and drafted recommendations which were then evaluated by the expert panel using a modified Delphi voting process. The process yielded 21 recommendations on the structure and process of essential services required for effective DoC-focused rehabilitation, organized into 4 categories: diagnostic and prognostic assessment (4 recommendations), treatment (11 recommendations), transitioning care/long-term care needs (5 recommendations), and management of ethical issues (1 recommendation). With few exceptions, these recommendations focus on infrastructure requirements and operating procedures for the provision of DoC-focused neurorehabilitation services across subacute and postacute settings.


Asunto(s)
Lesiones Traumáticas del Encéfalo/rehabilitación , Trastornos de la Conciencia/rehabilitación , Medicina Física y Rehabilitación/normas , Centros de Rehabilitación/normas , Humanos , Investigación en Rehabilitación , Sociedades Médicas , Estados Unidos
4.
Brain Inj ; 34(8): 1127-1134, 2020 07 02.
Artículo en Inglés | MEDLINE | ID: mdl-32543235

RESUMEN

OBJECTIVE: To review the historical, clinical, radiographic, and outcome characteristics of individuals diagnosed with an acquired brain injury (ABI) due to cerebral fat embolism syndrome (CFES) with and without features of traumatic brain injury (TBI). METHODS: A retrospective chart review of individuals with the diagnosis of CFES admitted to an ABI rehabilitation program. Cases were divided into two cohorts 1) individuals with evidence of classic features of CFES alone, and 2) individuals with evidence of CFES in conjunction with features of TBI. RESULTS: 14 individuals were identified, seven individuals with diagnosis of CFES alone, and seven with CFES and TBI. Median initial GCS was 15 for the isolated CFES cohort and 8 for the dual diagnosis cohort (p =.006). There were clear qualitative differences in MRI findings with characteristic patterns between the two groups. CONCLUSION: The diagnosis of CFES is an important consideration for individuals who have new neurologic impairment following a trauma, especially in cases where initial GCS was high. MRI has an important role in differentiating lesions of CFES from TBI and should be utilized for prognostication and management decisions. Individuals with neurologic injury secondary to CFES had good functional recovery outcomes as measured by Glasgow Outcome Scale.


Asunto(s)
Lesiones Traumáticas del Encéfalo , Lesiones Encefálicas , Embolia Grasa , Lesiones Traumáticas del Encéfalo/complicaciones , Lesiones Traumáticas del Encéfalo/diagnóstico por imagen , Embolia Grasa/diagnóstico por imagen , Embolia Grasa/etiología , Escala de Coma de Glasgow , Escala de Consecuencias de Glasgow , Humanos , Estudios Retrospectivos
5.
Brain Inj ; 33(9): 1194-1199, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31215813

RESUMEN

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.


Asunto(s)
Lesiones Traumáticas del Encéfalo/complicaciones , Agitación Psicomotora/etiología , Trastornos del Sueño-Vigilia/etiología , Actigrafía , Adulto , Anciano , Amnesia/etiología , Amnesia/psicología , Lesiones Traumáticas del Encéfalo/rehabilitación , Femenino , Humanos , Puntaje de Gravedad del Traumatismo , Tiempo de Internación , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Resultado del Tratamiento , Vigilia , Adulto Joven
6.
Brain Inj ; 33(5): 610-617, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30663426

RESUMEN

OBJECTIVE: To study the predictive relationship among persons with traumatic brain injury (TBI) between an objective indicator of injury severity (the adapted Marshall computed tomography [CT] classification scheme) and clinical indicators of injury severity in the acute phase, functional outcomes at inpatient rehabilitation discharge, and functional and participation outcomes at 1 year after injury, including death. PARTICIPANTS: The sample involved 4895 individuals who received inpatient rehabilitation following acute hospitalization for TBI and were enrolled in the Traumatic Brain Injury Model Systems National Database between 1989 and 2014. DESIGN: Head CT variables for each person were fit into adapted Marshall CT classification categories I through IV. MAIN MEASURES: Prediction models were developed to determine the amount of variability explained by the CT classification categories compared with commonly used predictors, including a clinical indicator of injury severity. RESULTS: The adapted Marshall classification categories aided only in the prediction of craniotomy or craniectomy during acute hospitalization, otherwise making no meaningful contribution to variance in the multivariable models predicting outcomes at any time point after injury. CONCLUSION: Results suggest that head CT findings classified in this manner do not inform clinical discussions related to functional prognosis or rehabilitation planning after TBI. ABBREVIATIONS: CT: computed tomography; DRS: disability rating scale; EGOS: extended Glasgow outcome scale; FIM: functional independence measure; NDB: National Data Base; PTA: posttraumatic amnesia; RLOS: rehabilitation length of stay; SPOS: semipartial omega squared statistic; TBI: traumatic brain injury; TBIMS: Traumatic Brain Injury Model Systems.


Asunto(s)
Lesiones Traumáticas del Encéfalo/diagnóstico por imagen , Encéfalo/diagnóstico por imagen , Evaluación de la Discapacidad , Adulto , Factores de Edad , Anciano , Lesiones Traumáticas del Encéfalo/rehabilitación , Femenino , Escala de Consecuencias de Glasgow , Humanos , Puntaje de Gravedad del Traumatismo , Masculino , Persona de Mediana Edad , Neuroimagen , Valor Predictivo de las Pruebas , Pronóstico , Recuperación de la Función , Tomografía Computarizada por Rayos X , Adulto Joven
7.
Arch Phys Med Rehabil ; 98(2): 312-319, 2017 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-27670926

RESUMEN

OBJECTIVE: To describe incidence, clinical characteristics, complications, and outcomes in posttraumatic hydrocephalus (PTH) after traumatic brain injury (TBI) for patients treated in an inpatient rehabilitation program. DESIGN: Cohort study with retrospective comparative analysis. SETTING: Inpatient rehabilitation hospital. PARTICIPANTS: All patients admitted for TBI from 2009 to 2013 diagnosed with PTH (N=59), defined as ventriculomegaly, delayed clinical recovery discordant with injury severity, hydrocephalus symptoms, or positive lumbar puncture results. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Primary measures were incidence of PTH and patient and injury characteristics. Secondary measures included frequency and timing of ventriculoperitoneal (VP) shunt, related complications, emergence from and duration of posttraumatic amnesia (PTA), Rancho Los Amigos Scale (RLAS) score, and FIM score at rehabilitation admission and discharge. RESULTS: Of 701 patients with TBI admitted, 59 (8%) were diagnosed with PTH. Of these, the median age was 25 years, with 73% being men. At initial presentation, 52 (88%) did not follow commands. Fifty-two (90%) patients with PTH had a VP shunt placed. Median time from injury to shunt placement was 69 (range, 9-366) days. Seven (12%) patients with PTH experienced postsurgical seizure, 3 (6%) had shunt infection, and 7 (12%) had shunt malfunction. Thirty-six (61%) patients with PTH emerged from PTA during rehabilitation. Median total FIM score at rehabilitation admission was 20 (range, 18-76), and at discharge it was 43 (range, 18-118). Injury severity predicted outcome at rehabilitation admission, whereas shunt timing predicted outcome at rehabilitation discharge. CONCLUSIONS: Incidence of PTH was observed in 8% of patients with TBI in inpatient rehabilitation. Earlier shunting predicted improved outcome during rehabilitation. Future studies should prospectively examine clinical decision rules, type, and timing of intervention and the coeffectiveness of rehabilitation treatment on outcomes.


Asunto(s)
Lesiones Encefálicas/epidemiología , Lesiones Encefálicas/rehabilitación , Derivaciones del Líquido Cefalorraquídeo/métodos , Hidrocefalia/epidemiología , Hidrocefalia/cirugía , Adolescente , Adulto , Anciano , Amnesia/epidemiología , Derivaciones del Líquido Cefalorraquídeo/efectos adversos , Femenino , Escala de Coma de Glasgow , Humanos , Incidencia , Tiempo de Internación , Masculino , Persona de Mediana Edad , Pronóstico , Recuperación de la Función , Centros de Rehabilitación , Estudios Retrospectivos , Adulto Joven
8.
Neurotrauma Rep ; 4(1): 447-457, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37475977

RESUMEN

The Extended Glasgow Outcome Scale (GOSE) is accepted as the primary outcome measure in registrational studies for traumatic brain injury (TBI). The Disability Rating Scale (DRS) is used to assess functional progress from initial acute injury, through rehabilitation and reintegration into the community and life. For these reasons, the DRS is an alternative measure for assessing meaningful global outcomes in chronic TBI. The objective of this study was to determine the minimally clinically important difference (MCID) for the DRS in chronic TBI, by determining the magnitude of DRS change associated with the MCID for the GOSE of 1 point. This study is a retrospective analysis of the multi-center, prospective, longitudinal, Traumatic Brain Injury Model Systems National Database of persons with outcomes at 1, 2, and 5 years and every 5 years thereafter post-injury. Spearman's correlations for dynamic and static relationships between the DRS and GOSE were significant. For the 1-point MCID for the GOSE, the dynamic MCID estimate for the DRS of a -0.68-point change was calculated as the mean DRS change associated with the difference of the GOSE score between year 1 and year 2 (score range, 3-8), using all persons in the study (n = 11,102), whereas the exploratory static MCID estimate for the DRS of -1.28 points was calculated from the slope of the best-fit line between the DRS and GOSE at year 1 follow-up (score range, 3-8; n = 13,415). The final MCID for the DRS was calculated by using the triangulation method (i.e., the arithmetic mean of the dynamic and exploratory static MCID estimates), which resulted in a -1.0-point change. The significant correlation between the DRS and GOSE has allowed for the establishment of a -1.0-point MCID for the DRS, which supports the use of the DRS as an alternative primary outcome measure for chronic TBI research studies, including clinical trials.

9.
J Music Ther ; 58(1): 70-94, 2021 Mar 16.
Artículo en Inglés | MEDLINE | ID: mdl-33095230

RESUMEN

Rhythmic auditory stimulation (RAS) has been well researched with stroke survivors and individuals who have Parkinson's disease, but little research exists on RAS with people who have experienced traumatic brain injury (TBI). This pilot study aimed to (1) assess the feasibility of the study design and (2) explore potential benefits. This single-arm clinical trial included 10 participants who had a 2-week control period between baseline and pretreatment. Participants had RAS daily for a 2-week treatment period and immediately completed post-treatment assessments. Participants then had a 1-week control period and completed follow-up assessment. The starting cadence was evaluated each day of the intervention period due to the variation in daily functioning in this population. All 10 participants were 1-20 years post-TBI with notable deviations in spatial-temporal aspects of gait including decreased velocity, step symmetry, and cadence. All participants had a high risk of falling as defined by achieving less than 22 on the Functional Gait Assessment (FGA). The outcome measures included the 10-m walk test, spatial and temporal gait parameters, FGA, and Physical Activity Enjoyment Scale. There were no adverse events during the study and gait parameters improved. After the intervention, half of the participants achieved a score of more than 22 on the FGA, indicating that they were no longer at high risk of experiencing falls.


Asunto(s)
Estimulación Acústica/métodos , Lesiones Traumáticas del Encéfalo/rehabilitación , Terapia por Ejercicio , Marcha/fisiología , Musicoterapia/métodos , Rehabilitación Neurológica/métodos , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Equilibrio Postural , Postura , Resultado del Tratamiento , Caminata , Adulto Joven
10.
JAMA Neurol ; 78(5): 548-557, 2021 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-33646273

RESUMEN

Importance: Traumatic brain injury (TBI) leads to 2.9 million visits to US emergency departments annually and frequently involves a disorder of consciousness (DOC). Early treatment, including withdrawal of life-sustaining therapies and rehabilitation, is often predicated on the assumed worse outcome of disrupted consciousness. Objective: To quantify the loss of consciousness, factors associated with recovery, and return to functional independence in a 31-year sample of patients with moderate or severe brain trauma. Design, Setting, and Participants: This cohort study analyzed patients with TBI who were enrolled in the Traumatic Brain Injury Model Systems National Database, a prospective, multiyear, longitudinal database. Patients were survivors of moderate or severe TBI who were discharged from acute hospitalization and admitted to inpatient rehabilitation from January 4, 1989, to June 19, 2019, at 1 of 23 inpatient rehabilitation centers that participated in the Traumatic Brain Injury Model Systems program. Follow-up for the study was through completion of inpatient rehabilitation. Exposures: Traumatic brain injury. Main Outcomes and Measures: Outcome measures were Glasgow Coma Scale in the emergency department, Disability Rating Scale, posttraumatic amnesia, and Functional Independence Measure. Patient-related data included demographic characteristics, injury cause, and brain computed tomography findings. Results: The 17 470 patients with TBI analyzed in this study had a median (interquartile range [IQR]) age at injury of 39 (25-56) years and included 12 854 male individuals (74%). Of these patients, 7547 (57%) experienced initial loss of consciousness, which persisted to rehabilitation in 2058 patients (12%). Those with persisting DOC were younger; had more high-velocity injuries; had intracranial mass effect, intraventricular hemorrhage, and subcortical contusion; and had longer acute care than patients without DOC. Eighty-two percent (n = 1674) of comatose patients recovered consciousness during inpatient rehabilitation. In a multivariable analysis, the factors associated with consciousness recovery were absence of intraventricular hemorrhage (adjusted odds ratio [OR], 0.678; 95% CI, 0.532-0.863; P = .002) and intracranial mass effect (adjusted OR, 0.759; 95% CI, 0.595-0.968; P = .03). Functional improvement (change in total functional independence score from admission to discharge) was +43 for patients with DOC and +37 for those without DOC (P = .002), and 803 of 2013 patients with DOC (40%) became partially or fully independent. Younger age, male sex, and absence of intraventricular hemorrhage, intracranial mass effect, and subcortical contusion were associated with better functional outcome. Findings were consistent across the 3 decades of the database. Conclusions and Relevance: This study found that DOC occurred initially in most patients with TBI and persisted in some patients after rehabilitation, but most patients with persisting DOC recovered consciousness during rehabilitation. This recovery trajectory may inform acute and rehabilitation treatment decisions and suggests caution is warranted in consideration of withdrawing or withholding care in patients with TBI and DOC.


Asunto(s)
Lesiones Traumáticas del Encéfalo/terapia , Lesiones Encefálicas/terapia , Estado de Conciencia/fisiología , Recuperación de la Función/fisiología , Adulto , Lesiones Encefálicas/complicaciones , Lesiones Traumáticas del Encéfalo/complicaciones , Estudios de Cohortes , Trastornos de la Conciencia/terapia , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Alta del Paciente/estadística & datos numéricos , Modalidades de Fisioterapia/estadística & datos numéricos , Centros de Rehabilitación/estadística & datos numéricos
11.
J Neurotrauma ; 38(5): 593-603, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33256501

RESUMEN

Medical conditions co-occurring with traumatic brain injury (TBI) are associated with outcomes, and comorbidity indices such as Charlson and Elixhauser are used in TBI research, but they are not TBI specific. The purpose of this research was to develop an index or indices of medical conditions, identified in acute care after moderate to severe TBI, that are associated with outcomes at rehabilitation discharge. Using the TBI Model Systems National Database, the International Classification of Diseases, Ninth Revision (ICD-9) and Tenth Revision (ICD-10) codes of 8988 participants were converted to Healthcare Cost and Utilization Project (HCUP) diagnostic categories. Poisson regression models were built predicting Disability Rating Scale and Functional Independence Measure Cognitive and Motor subscale scores from HCUP categories after controlling for demographic and injury characteristics. Unweighted, weighted, and anchored indices based on the outcome models predicted 7.5-14.3% of the variance in the observed outcomes. When the indices were applied to a new validation sample of 1613 cases, however, only 2.6-6.6% of the observed outcomes were predicted. Therefore, no models or indices were recommended for future use, but several study findings are highlighted suggesting the importance and the potential for future research in this area.


Asunto(s)
Lesiones Traumáticas del Encéfalo/clasificación , Lesiones Traumáticas del Encéfalo/diagnóstico , Bases de Datos Factuales/clasificación , Clasificación Internacional de Enfermedades , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Conmoción Encefálica/clasificación , Conmoción Encefálica/diagnóstico , Conmoción Encefálica/epidemiología , Lesiones Traumáticas del Encéfalo/epidemiología , Comorbilidad , Investigación Empírica , Femenino , Indicadores de Salud , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Adulto Joven
12.
Neurology ; 2021 Jan 04.
Artículo en Inglés | MEDLINE | ID: mdl-33397772

RESUMEN

OBJECTIVE: To determine if chronic motor deficits secondary to traumatic brain injury (TBI) can be improved by implantation of allogeneic modified bone marrow-derived mesenchymal stromal/stem cells (SB623). METHODS: This 6-month interim analysis of the 1-year double-blind, randomized, surgical sham-controlled, phase 2 STEMTRA trial (NCT02416492) evaluated safety and efficacy of the stereotactic intracranial implantation of SB623 in patients with stable chronic motor deficits secondary to TBI. Patients in this multi-center trial (N = 63) underwent randomization in a 1:1:1:1 ratio to 2.5 × 106, 5.0 × 106, 10 × 106 SB623 cells or control. Safety was assessed in patients who underwent surgery (N = 61), and efficacy in the modified intent-to-treat population of randomized patients who underwent surgery (N = 61; SB623 = 46, control = 15). RESULTS: The primary efficacy endpoint of significant improvement from baseline of Fugl-Meyer Motor Scale score at 6 months for SB623-treated patients was achieved. SB623-treated patients improved by (LS mean [SE]) +8.3 (1.4) vs +2.3 (2.5) for control at 6 months, the LS mean difference was 6.0 (95% CI: 0.3-11.8); p = 0.040. Secondary efficacy endpoints improved from baseline, but were not statistically significant vs control at 6 months. There were no dose-limiting toxicities or deaths, and 100% of SB623-treated patients experienced treatment-emergent adverse events vs 93.3% of control patients (p = 0.25). CONCLUSIONS: SB623 cell implantation appeared to be safe and well tolerated, and patients implanted with SB623 experienced significant improvement from baseline motor status at 6 months compared to controls. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that implantation of SB623 was well tolerated and associated with improvement in motor status.

14.
NeuroRehabilitation ; 46(3): 355-368, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32250330

RESUMEN

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.


Asunto(s)
Andrógenos , Lesiones Traumáticas del Encéfalo , Eunuquismo , Testosterona , Adolescente , Adulto , Anciano , Andrógenos/administración & dosificación , Andrógenos/efectos adversos , Andrógenos/uso terapéutico , Lesiones Traumáticas del Encéfalo/complicaciones , Lesiones Traumáticas del Encéfalo/fisiopatología , Lesiones Traumáticas del Encéfalo/rehabilitación , Método Doble Ciego , Eunuquismo/tratamiento farmacológico , Eunuquismo/etiología , Humanos , Masculino , Persona de Mediana Edad , Recuperación de la Función , Testosterona/administración & dosificación , Testosterona/efectos adversos , Testosterona/uso terapéutico , Adulto Joven
15.
Neurorehabil Neural Repair ; 34(2): 111-121, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31884895

RESUMEN

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.


Asunto(s)
Lesiones Traumáticas del Encéfalo/rehabilitación , Rehabilitación Neurológica , Evaluación de Procesos y Resultados en Atención de Salud , Higiene del Sueño , Trastornos del Sueño-Vigilia/rehabilitación , Actigrafía , Adulto , Lesiones Traumáticas del Encéfalo/complicaciones , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Fototerapia , Proyectos Piloto , Índice de Severidad de la Enfermedad , Trastornos del Sueño del Ritmo Circadiano/etiología , Trastornos del Sueño del Ritmo Circadiano/rehabilitación , Higiene del Sueño/fisiología , Trastornos del Sueño-Vigilia/etiología , Adulto Joven
17.
J Neurosurg ; : 1-12, 2018 Feb 23.
Artículo en Inglés | MEDLINE | ID: mdl-29473779

RESUMEN

OBJECTIVE Posttraumatic hydrocephalus (PTH) is a frequent sequela of traumatic brain injury (TBI) and complication of related cranial surgery. The roles of PTH and the timing of cerebrospinal fluid (CSF) shunt placement in TBI outcome have not been well described. The goal of this study was to assess the impact of hydrocephalus and timing of ventriculoperitoneal (VP) shunt placement on outcome during inpatient rehabilitation after TBI. METHODS In this cohort study, all TBI patients admitted to Craig Hospital between 2009 and 2013 were evaluated for PTH, defined as ventriculomegaly, and hydrocephalus symptoms, delayed or deteriorating recovery, or elevated opening pressure on lumbar puncture. Extent of ventriculomegaly was quantified by the Evans index from CT scans. Outcome measures were emergence from and duration of posttraumatic amnesia (PTA) and functional status as assessed by means of the Functional Independence Measure (FIM). Findings in this group were compared to findings in a group of TBI patients without PTH (controls) who were admitted for inpatient rehabilitation during the same study period and met specific criteria for inclusion. RESULTS A total of 701 patients were admitted with TBI during the study period. Of these patients, 59 (8%) were diagnosed with PTH and were included in this study as the PTH group, and 204 who were admitted for rehabilitation and met the criteria for inclusion as controls constituted the comparison group (no-PTH group). PTH was associated with initial postinjury failure to follow commands, midline shift or cistern compression, subcortical contusion, and craniotomy or craniectomy. In multivariable analyses, independent predictors of longer PTA duration and lower FIM score at rehabilitation discharge were PTH, emergency department Glasgow Coma Scale motor score < 6, and longer time from injury to rehabilitation admission. PTH accounted for a 51-day increase in PTA duration and a 29-point reduction in discharge FIM score. In 40% of PTH patients with preshunt CT brain imaging analyzed, ventriculomegaly (Evans index > 0.3) was observed 3 or more days before VP shunt placement (median 10 days, range 3-102 days). Among PTH patients who received a VP shunt, earlier placement was associated with better outcome by all measures assessed and independently predicted better FIM total score and shorter PTA duration. CONCLUSIONS Posttraumatic hydrocephalus predicts worse outcome during inpatient rehabilitation, with poorer functional outcomes and longer duration of PTA. In shunt-treated PTH patients, earlier CSF shunting predicted improved recovery. These results suggest that clinical vigilance for PTH onset and additional studies on timing of CSF diversion are warranted.

18.
NeuroRehabilitation ; 43(3): 277-285, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30373965

RESUMEN

BACKGROUND: As awareness of disrupted sleep in patients with traumatic brain injury (TBI) increases so does interest in finding objective measures of sleep. As a result, many clinicians are turning to actigraphs to monitor sleep in patients with altered consciousness. Actigraphs are accelerometers which have been used in sleep research for over four decades. OBJECTIVE: The purpose of the present study was to determine the best method for scoring actigraphs in a TBI population and to describe the benefits and pitfalls of using actigraphs with patients on a brain injury rehabilitation unit. METHODS: A retrospective chart review of 43 patients compared three different ways of scoring night time rest periods: autoscoring, manual scoring, and set interval scoring for the sleep parameters of sleep efficiency, wakefulness after sleep onset, and total sleep time. Nursing compliance with using the event marker on the device to set rest period was also analyzed. RESULTS: The autoscoring method of determining the rest interval showed an inflation of sleep efficiency. For each sleep parameter compared, the strongest correlations were observed between the manual and set interval scoring methods. Compliance using event markers to set rest interval was low (16.7%). CONCLUSIONS: Set interval scoring is the most efficient method to determine the rest interval in TBI patients. The use of event markers was an unreliable method to determine rest period.


Asunto(s)
Actigrafía/métodos , Lesiones Traumáticas del Encéfalo/fisiopatología , Hospitales de Rehabilitación/métodos , Trastornos del Sueño-Vigilia/fisiopatología , Sueño/fisiología , Vigilia/fisiología , Adolescente , Adulto , Anciano , Encéfalo/fisiopatología , Lesiones Traumáticas del Encéfalo/diagnóstico , Lesiones Traumáticas del Encéfalo/rehabilitación , Estudios de Cohortes , Femenino , Humanos , Pacientes Internos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Trastornos del Sueño-Vigilia/diagnóstico , Trastornos del Sueño-Vigilia/rehabilitación , Adulto Joven
19.
J Neurotrauma ; 2018 Aug 28.
Artículo en Inglés | MEDLINE | ID: mdl-29954258

RESUMEN

Neuroprotective treatments that have shown promise in reducing secondary injury and improving recovery in animal models of traumatic brain injury (TBI) have not been found effective to date in humans. One reason may be the delay after injury in initiating treatment. Statin medications are among the promising neuroprotective agents in animal models, and their presence in the bloodstream of many individuals at the time of injury might optimize their clinical impact. This observational study conducted by a subset of centers participating in the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)-funded TBI Model System program sought to examine the effects of taking statin medication at the time injury on functional outcomes. Participants >50 years of age were prospectively enrolled during patient rehabilitation. Demographic data, cardiovascular history, and brain injury history were obtained through chart abstraction and interview. Prescription medication use in the year prior to enrollment was determined from a national pharmacy search service. Propensity scoring was used to create 49 pairs of participants who were well matched on demographic and clinical attributes but discordant for statin use. The treated and untreated participants did not differ on initial Glasgow Coma Score, time until commands were followed, duration of post-traumatic amnesia, or Functional Independence Measure (FIM) scores at rehabilitation admission, discharge, or 1 year post-injury, or on acute or rehabilitation hospital lengths of stay. Evidence of greater and lesser statin compliance was not associated with outcome. This study did not provide support for a clinically important benefit of statin use at the time of moderate to severe TBI.

20.
Anesth Analg ; 104(1): 163-5, 2007 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-17179263

RESUMEN

BACKGROUND: The locked-in syndrome is defined as quadriplegia and anarthria (loss of articulate speech) with the preservation of consciousness. It is typically caused by a lesion to the ventral pons. Conversion disorder is the deficit of voluntary motor or sensory function requiring an extensive work-up to exclude any organic cause. METHODS AND RESULTS: After surgery for an implantation of a spinal cord stimulator, a 42-year-old woman presented with quadriplegia and lower facial diplegia, but was able to open and blink her eyes. We found no organic causes to explain her condition after appropriate radiological studies looking for intracranial or intraspinal causes, and reversal drugs were administered with no immediate effect. Over the course of several hours, the patient gradually recovered and was discharged the following day. A psychology consultation was obtained during her stay and she was found to meet the criteria for a conversion disorder to explain her condition. CONCLUSIONS: Before considering a psychological cause, all organic factors should be excluded with proper tests and consultations, as conversion disorder is a diagnosis of exclusion. We report a patient who, after implantation of a spinal cord stimulator, manifested locked-in syndrome resulting from a conversion disorder.


Asunto(s)
Trastornos de Conversión/etiología , Terapia por Estimulación Eléctrica/efectos adversos , Cuadriplejía/etiología , Médula Espinal , Adulto , Trastornos de Conversión/psicología , Femenino , Humanos
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