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1.
Trials ; 21(1): 964, 2020 Nov 23.
Artículo en Inglés | MEDLINE | ID: mdl-33228756

RESUMEN

BACKGROUND: Spine metastasis is a common occurrence in cancer patients and results in pain, neurologic deficits, decline in performance status, disability, inferior quality of life (QOL), and reduction in ability to receive cancer-directed therapies. Conventional external beam radiation therapy (EBRT) is associated with modest rates of pain relief, high rates of disease recurrence, low response rates for those with radioresistant histologies, and limited improvement in neurologic deficits. The addition of radiofrequency ablation/percutaneous vertebral augmentation (RFA/PVA) to index sites together with EBRT may improve pain response rates and corresponding quality of life. METHODS/DESIGN: This is a single-center, prospective, randomized, controlled trial in patients with spine metastasis from T5-L5, stratified according to tumor type (radioresistant vs. radiosensitive) in which patients in each stratum will be randomized in a 2:1 ratio to either RFA/PVA and EBRT or EBRT alone. All patients will be treated with EBRT to a dose of 20-30 Gy in 5-10 fractions. The target parameters will be measured and recorded at the baseline clinic visit, and daily at home with collection of weekly measurements at 1, 2, and 3 weeks after treatment, and at 3, 6, 12, and 24 months following treatment with imaging and QOL assessments. DISCUSSION: The primary objective of this randomized trial is to determine whether RFA/PVA in addition to EBRT improves pain control compared to palliative EBRT alone for patients with spine metastasis, defined as complete or partial pain relief (measured using the Numerical Rating Pain Scale [NRPS]) at 3 months. Secondary objectives include determining whether combined modality treatment improves the rapidity of pain response, duration of pain response, patient reported pain impact, health utility, and overall QOL. TRIAL REGISTRATION: ClinicalTrials.gov NCT04375891 . Registered on 5 May 2020.


Asunto(s)
Ablación por Radiofrecuencia , Neoplasias de la Columna Vertebral , Humanos , Recurrencia Local de Neoplasia , Dimensión del Dolor , Estudios Prospectivos , Calidad de Vida , Ablación por Radiofrecuencia/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Neoplasias de la Columna Vertebral/radioterapia
2.
PLoS One ; 12(9): e0183711, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28902876

RESUMEN

INTRODUCTION: Deep brain stimulation (DBS) is an effective treatment for multiple movement disorders and shows substantial promise for the treatment of some neuropsychiatric and other disorders of brain neurocircuitry. Optimal neuroanatomical lead position is a critical determinant of clinical outcomes in DBS surgery. Lead migration, defined as an unintended post-operative displacement of the DBS lead, has been previously reported. Despite several reports, however, there have been no systematic investigations of this issue. This study aimed to: 1) quantify the incidence of lead migration in a large series of DBS patients, 2) identify potential risk factors contributing to DBS lead migration, and 3) investigate the practical importance of this complication by correlating its occurrence with clinical outcomes. METHODS: A database of all DBS procedures performed at UF was queried for patients who had undergone multiple post-operative DBS lead localization imaging studies separated by at least two months. Bilateral DBS implantation has commonly been performed as a staged procedure at UF, with an interval of six or more months between sides. To localize the position of each DBS lead, a head CT is acquired ~4 weeks after lead implantation and fused to the pre-operative targeting MRI. The fused targeting images (MR + stereotactic CT) acquired in preparation for the delayed second side lead implantation provide an opportunity to repeat the localization of the first implanted lead. This paradigm offers an ideal patient population for the study of delayed DBS lead migration because it provides a large cohort of patients with localization of the same implanted DBS lead at two time points. The position of the tip of each implanted DBS lead was measured on both the initial post-operative lead localization CT and the delayed CT. Lead tip displacement, intracranial lead length, and ventricular indices were collected and analyzed. Clinical outcomes were characterized with validated rating scales for all cases, and a comparison was made between outcomes of cases with lead migration versus those where migration of the lead did not occur. RESULTS: Data from 138 leads in 132 patients with initial and delayed lead localization CT scans were analyzed. The mean distance between initial and delayed DBS lead tip position was 2.2 mm and the mean change in intracranial lead length was 0.45 mm. Significant delayed migration (>3 mm) was observed in 17 leads in 16 patients (12.3% of leads, 12.1% of patients). Factors associated with lead migration were: technical error, repetitive dystonic head movement, and twiddler's syndrome. Outcomes were worse in dystonia patients with lead migration (p = 0.035). In the PD group, worse clinical outcomes trended in cases with lead migration. CONCLUSIONS: Over 10% of DBS leads in this large single center cohort were displaced by greater than 3 mm on delayed measurement, adversely affecting outcomes. Multiple risk factors emerged, including technical error during implantation of the DBS pulse generator and failure of lead fixation at the burr hole site. We hypothesize that a change in surgical technique and a more effective lead fixation device might mitigate this problem.


Asunto(s)
Estimulación Encefálica Profunda/efectos adversos , Estimulación Encefálica Profunda/estadística & datos numéricos , Electrodos Implantados/efectos adversos , Migración de Cuerpo Extraño/epidemiología , Complicaciones Posoperatorias/epidemiología , Adulto , Anciano , Encéfalo/diagnóstico por imagen , Encéfalo/cirugía , Estimulación Encefálica Profunda/instrumentación , Estimulación Encefálica Profunda/métodos , Trastornos Distónicos/epidemiología , Trastornos Distónicos/terapia , Femenino , Migración de Cuerpo Extraño/etiología , Humanos , Incidencia , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Enfermedad de Parkinson/epidemiología , Enfermedad de Parkinson/terapia , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento
3.
Stereotact Funct Neurosurg ; 91(2): 129-33, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-23343665

RESUMEN

Huntington's disease (HD) is an autosomal dominant and progressive neurodegenerative syndrome characterized by motor, cognitive and psychiatric manifestations. Chorea and dystonia are features that may be troublesome to some patients and may potentially prove unresponsive to pharmacological treatments. There are several reports on the results of globus pallidus internus deep brain stimulation (DBS) surgery for HD. In these published cases, DBS was utilized mainly to treat disabling chorea. We report our experience with 2 HD cases treated with DBS. The cases illustrate a differential response with a better outcome in the choreic presentation compared to the dystonic presentation. Additionally, DBS worsened gait features in both cases.


Asunto(s)
Corea/terapia , Estimulación Encefálica Profunda , Distonía/terapia , Enfermedad de Huntington/terapia , Adulto , Corea/diagnóstico , Corea/epidemiología , Estimulación Encefálica Profunda/métodos , Distonía/diagnóstico , Distonía/epidemiología , Femenino , Humanos , Enfermedad de Huntington/diagnóstico , Enfermedad de Huntington/epidemiología , Masculino , Resultado del Tratamiento
4.
J Grad Med Educ ; 4(4): 467-71, 2012 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-24294423

RESUMEN

BACKGROUND: Previous studies suggest that nonurgent pages comprise a substantial portion of the pages received by residents while on duty. We evaluated the number, type, and urgency of pages received and the task being performed at the time of paging by on-call junior neurosurgery residents at a large teaching hospital, with the aim of providing insight into mechanisms that can be developed to improve paging patterns and ultimately reduce physician distractions due to nonurgent communications. METHODS: For eight 12-hour call sessions, a medical student shadowed the on-call junior neurosurgery resident and recorded all pages received and the time, paging number and location, priority of the page (nonurgent, urgent, or emergency), and the activity the resident performed when the page was received. During one 5-hour session, a recorder measured the amount of time spent returning pages. RESULTS: During the study period, 439 communications were recorded (mean of 54.9 per 12-hour session; range, 33-75). Communications occurred at a rate of every 13 minutes and ranged from every 34 minutes to every 8.7 minutes. Paging remained frequent even during the hours when on-call residents are most likely to sleep (2-5 am), with an average of 4 communications per hour. The time to return pages ranged from 15 to 174 seconds (mean, 79.7 seconds). Most pages were nonurgent (68.3%) and occurred during patient care activities (65%). CONCLUSIONS: Paging communications were frequent. Most pages were nonurgent and were received during important patient care activities. This suggests that a viable solution must address the work context of the individual being paged and the individual initiating the page to ensure that urgent communications are properly prioritized and attended to.

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