A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder

Deep brain stimulation (DBS) has been proposed for severe, chronic, treatment-refractory obsessive-compulsive disorder (OCD) patients. Although serious adverse events can occur, only a few studies report on the safety profile of DBS for psychiatric disorders. In a prospective, open-label, interventional multi-center study, we examined the safety and efficacy of electrical stimulation in 30 patients with DBS electrodes bilaterally implanted in the anterior limb of the internal capsule. Safety, efficacy, and functionality assessments were performed at 3, 6, and 12 months post implant. An independent Clinical Events Committee classified and coded all adverse events (AEs) according to EN ISO14155:2011. All patients experienced AEs (195 in total), with the majority of these being mild (52% of all AEs) or moderate (37%). Median time to resolution was 22 days for all AEs and the etiology with the highest AE incidence was 'programming/stimulation' (in 26 patients), followed by 'New illness, injury, condition' (13 patients) and 'pre-existing condition, worsening or exacerbation' (11 patients). Sixteen patients reported a total of 36 serious AEs (eight of them in one single patient), mainly transient anxiety and affective symptoms worsening (20 SAEs). Regarding efficacy measures, Y-BOCS reduction was 42% at 12 months and the responder rate was 60%. Improvements in GAF, CGI, and EuroQol-5D index scores were also observed. In sum, although some severe AEs occurred, most AEs were mild or moderate, transient and related to programming/stimulation and tended to resolve by adjustment of stimulation. In a severely treatment-resistant population, this open-label study supports that the potential benefits outweigh the potential risks of DBS

Manual de simulación clínica en especialidades médicas

Manual sobre técnicas y modos de simulación clínica en diversas especialidades médicas.La enseñanza y formación en medicina necesita el uso de la simulación. Existen evidencias de su uso desde hace cientos de años, pero, en los últimos años se ha incrementado y diseminado. La simulación clínica está validada científicamente en múltiples contextos médicos y de otras áreas profesionales de la salud. Y es considerada de gran importancia como proceso de entrenamiento y de mejora de las competencias y adquisición de habilidades médicas en campos que incluye desde la historia clínica, comunicación con el paciente, exploración, diagnóstico terapéutica médica-farmacológica y quirúrgica y seguridad al tratar al paciente. Hoy en día, para muchas técnicas y situaciones clínicas es inaceptable llegar junto a los pacientes sin un dominio adquirido en simulación. La simulación puede ocurrir sin el uso de recursos adicionales, solo las personas, o utilizando pocos o muchos recursos de baja hasta alta tecnología y se puede adaptar a los recursos disponibles, abarcando todas las áreas de conocimiento, y dentro de ellas competencias técnicas o actitudes, solas o en conjunto. El uso racional y basado en evidencia de la simulación es de la mayor importancia por la necesidad de una mayor efectividad y eficiencia en la transformación de los profesionales de la salud para que puedan mejorar su capacidad de atender a los pacientes. La simulación es también una buena herramienta de evaluación de competencias y habilidades en Medicina y otras disciplinas de las Ciencias de la Salud Este manual incluye técnicas y modos de simulación clínica en diversas especialidades médicas, útiles, para quien busque un manual práctico y actualizado.Cátedra de Mecenazgo de la Universidad de Málaga. Cátedra de Terapias Avanzadas en Patología Cardiovascular Cátedra de Mecenazgo de la Universidad de Málaga. Cátedra de Investigación Biomédica Quirón Salu

Alteraciones neuropsicológicas en pacientes con aneurismas cerebrales: tratamiento quirúrgico versus tratamiento endovascular

Objetivos. Describir el rendimiento neuropsicológico de pacientes con aneurismas cerebrales que han sido tratados mediante cirugía o embolización, y determinar la existencia de diferencias en función de la modalidad de tratamiento. Material y métodos. Serie clínica compuesta por 93 pacientes voluntarios, con aneurismas cerebrales, tratados mediante cirugía (n = 56) o embolización (n = 37). A ambos grupos se les realizó una evaluación neuropsicológica retrospectiva, al menos un año después de realizar el tratamiento. Resultados. En ambos grupos se encontraron pacientes con déficit neuropsicológicos. En el grupo de pacientes tratados quirúrgicamente el porcentaje de pacientes sin ninguna afectación neuropsicológica es del 35.7%, mientras que en el grupo de pacientes embolizados este porcentaje asciende al 43.2%. Los análisis muestran una ejecución mejor en el grupo de tratamiento endovascular, respecto al quirúrgico, sólo en memoria visual y en el recuerdo con claves de la memoria verbal. Conclusiones. Años después del tratamiento, un importante porcentaje de pacientes presenta alteraciones neuropsicológicas. El tratamiento endovascular se asocia con un mejor rendimiento en memoria visual y en el recuerdo con claves de la memoria verbal, aunque explica un porcentaje muy escaso de la varianza. Por lo tanto, en la explicación del deterioro neuropsicológico parece más importante el propio efecto de la hemorragia que la modalidad de intervención

A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder.

Deep brain stimulation (DBS) has been proposed for severe, chronic, treatment-refractory obsessive-compulsive disorder (OCD) patients. Although serious adverse events can occur, only a few studies report on the safety profile of DBS for psychiatric disorders. In a prospective, open-label, interventional multi-center study, we examined the safety and efficacy of electrical stimulation in 30 patients with DBS electrodes bilaterally implanted in the anterior limb of the internal capsule. Safety, efficacy, and functionality assessments were performed at 3, 6, and 12 months post implant. An independent Clinical Events Committee classified and coded all adverse events (AEs) according to EN ISO14155:2011. All patients experienced AEs (195 in total), with the majority of these being mild (52% of all AEs) or moderate (37%). Median time to resolution was 22 days for all AEs and the etiology with the highest AE incidence was 'programming/stimulation' (in 26 patients), followed by 'New illness, injury, condition' (13 patients) and 'pre-existing condition, worsening or exacerbation' (11 patients). Sixteen patients reported a total of 36 serious AEs (eight of them in one single patient), mainly transient anxiety and affective symptoms worsening (20 SAEs). Regarding efficacy measures, Y-BOCS reduction was 42% at 12 months and the responder rate was 60%. Improvements in GAF, CGI, and EuroQol-5D index scores were also observed. In sum, although some severe AEs occurred, most AEs were mild or moderate, transient and related to programming/stimulation and tended to resolve by adjustment of stimulation. In a severely treatment-resistant population, this open-label study supports that the potential benefits outweigh the potential risks of DBS.status: Published onlin

A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder.

Deep brain stimulation (DBS) has been proposed for severe, chronic, treatment-refractory obsessive-compulsive disorder (OCD) patients. Although serious adverse events can occur, only a few studies report on the safety profile of DBS for psychiatric disorders. In a prospective, open-label, interventional multi-center study, we examined the safety and efficacy of electrical stimulation in 30 patients with DBS electrodes bilaterally implanted in the anterior limb of the internal capsule. Safety, efficacy, and functionality assessments were performed at 3, 6, and 12 months post implant. An independent Clinical Events Committee classified and coded all adverse events (AEs) according to EN ISO14155:2011. All patients experienced AEs (195 in total), with the majority of these being mild (52% of all AEs) or moderate (37%). Median time to resolution was 22 days for all AEs and the etiology with the highest AE incidence was 'programming/stimulation' (in 26 patients), followed by 'New illness, injury, condition' (13 patients) and 'pre-existing condition, worsening or exacerbation' (11 patients). Sixteen patients reported a total of 36 serious AEs (eight of them in one single patient), mainly transient anxiety and affective symptoms worsening (20 SAEs). Regarding efficacy measures, Y-BOCS reduction was 42% at 12 months and the responder rate was 60%. Improvements in GAF, CGI, and EuroQol-5D index scores were also observed. In sum, although some severe AEs occurred, most AEs were mild or moderate, transient and related to programming/stimulation and tended to resolve by adjustment of stimulation. In a severely treatment-resistant population, this open-label study supports that the potential benefits outweigh the potential risks of DBS