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Una nueva investigación podría ayudar a millones de personas que sufren de ‘zumbido en los oídos’

En el ensayo clínico más grande de este tipo, los investigadores muestran que la combinación de estimulación acústica y eléctrica de la lengua puede reducir significativamente el tinnitus, comúnmente descrito como “zumbido en los oídos”. También encontraron que los efectos terapéuticos pueden mantenerse hasta 12 meses después del tratamiento.

Los hallazgos podrían ayudar a millones de personas, ya que el tinnitus afecta entre el 10 y el 15 por ciento de la población en todo el mundo. El estudio fue realizado por investigadores de la Universidad de Minnesota, el Trinity College, el Hospital St. James, la Universidad de Regensburg, la Universidad de Nottingham y la empresa irlandesa de dispositivos médicos Neuromod Devices Limited.

La investigación se publicó recientemente como artículo de portada de Science Translational Medicine.

El profesor asociado de la Universidad de Minnesota Hubert Lim en el Departamento de Ingeniería Biomédica (Facultad de Ciencias e Ingeniería) y el Departamento de Otorrinolaringología (Facultad de Medicina) fue el autor principal del estudio patrocinado por Neuromod Devices. Lim también se desempeña como director científico de Neuromod Devices.

El estudio representa el ensayo clínico de seguimiento más grande y más largo jamás realizado en el campo del tinnitus para un dispositivo médico con 326 participantes inscritos, que proporciona evidencia sobre la seguridad, eficacia y tolerabilidad del paciente de la neuromodulación bimodal para el tratamiento del tinnitus. Alrededor del 86 por ciento de los participantes que cumplieron con el tratamiento informaron una mejoría en la gravedad de los síntomas del tinnitus cuando se evaluaron después de 12 semanas de tratamiento, y muchos experimentaron un beneficio sostenido 12 meses después del tratamiento.

“Estoy realmente orgulloso de la capacidad de nuestra empresa para realizar un ensayo clínico aleatorizado a gran escala en dos países”, dijo Lim. “Este estudio rastreó los efectos terapéuticos posteriores al tratamiento durante 12 meses, que es la primera vez que el campo del tinnitus evalúa los resultados a largo plazo de un enfoque de dispositivos médicos. Los resultados son muy emocionantes y espero continuar nuestro trabajo para desarrollar un tratamiento de neuromodulación bimodal para ayudar a la mayor cantidad posible de pacientes con tinnitus “.

El estudio se realizó en el Centro de Investigación Clínica Wellcome Trust-HRB, el Hospital St. James, Dublín, Irlanda, y el Tinnituszentrum de la Universidad de Regensburg, Alemania. Hubo resultados terapéuticos consistentes en ambos sitios clínicos, sin eventos adversos graves. La sucursal de NAMSA con sede en Minneapolis, la única organización de investigación médica del mundo, guió y ayudó en el proceso de cierre del ensayo clínico de Neuromod Device.

El dispositivo de tratamiento de tinnitus utilizado en el estudio, ahora con la marca Lenire®, fue desarrollado por Neuromod Devices y consta de auriculares inalámbricos (Bluetooth®) que transmiten secuencias de tonos de audio con capas de ruido de banda ancha a ambos oídos, combinados con pulsos de estimulación eléctrica entregados a 32 electrodos en la punta de la lengua por un dispositivo patentado registrado como Tonguetip®. El tiempo, la intensidad y la entrega de los estímulos están controlados por un controlador de mano fácil de usar que cada participante está capacitado para operar. Antes de usar el tratamiento por primera vez, el dispositivo se configura según el perfil auditivo del paciente y se optimiza al nivel de sensibilidad del paciente para la estimulación de la lengua.

Para la prueba, se indicó a los participantes que usaran el dispositivo Lenire® durante 60 minutos al día durante 12 semanas. De los 326 participantes inscritos, el 83,7 por ciento usó el dispositivo en o por encima del nivel mínimo de cumplimiento de 36 horas durante el período de tratamiento de 12 semanas. Para los criterios de valoración primarios, los participantes lograron una reducción estadística y clínicamente significativa en la gravedad de los síntomas del tinnitus.

Cuando se completó el tratamiento, los participantes devolvieron sus dispositivos y fueron evaluados en tres visitas de seguimiento durante un máximo de 12 meses. Solo más del 66 por ciento de los participantes que completaron la encuesta de salida (n = 272) afirmaron que se habían beneficiado del uso del dispositivo, y el 77,8 por ciento (n = 270) dijeron que recomendarían el tratamiento para otras personas con tinnitus.

Los participantes en el estudio fueron evaluados y seleccionados según una lista predefinida de criterios de inclusión y exclusión para garantizar que el ensayo tuviera una muestra de distribución amplia de la población con tinnitus.


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