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LEXURE for Post-Stroke Aphasia

12 de mayo de 2026 actualizado por: Nunaps Inc

A Prospective, Multicenter, Randomized, Evaluator-Blinded, Confirmatory Study to Evaluate the Efficacy and Safety of LEXURE for Improving Language Function in Patients With Post-Stroke Aphasia

This study evaluates the efficacy of digital language rehabilitation using LEXURE for the treatment of post-stroke aphasia. Half of participants will receive structured language training using the LEXURE application, while the other half will receive workbook-based language training as an active comparator.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This study is a prospective, multicenter, randomized, evaluator-blinded confirmatory clinical trial designed to evaluate the efficacy and safety of LEXURE, a digital therapeutic for language in patients with post-stroke aphasia.

Eligible participants who provide informed consent will undergo screening and be randomized in a 1:1 ratio to either the LEXURE group or the control group.

LEXURE Group:

Participants assigned to the LEXURE group will receive structured digital language training using the LEXURE application. The training consists of multiple language tasks and will be performed for approximately 30 minutes per session, 5 times per week, for 10 weeks.

Control Group:

Participants assigned to the control group will perform structured language training using a workbook-based intervention. The training will consist of predefined language tasks and will be conducted for approximately 30 minutes per session, 5 times per week, for 10 weeks.

The primary efficacy endpoint will be assessed using the K-WAB/PK-WAB-R, and evaluations will be conducted by an independent, evaluator-blinded assessor.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

116

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Suekyung Jung
  • Número de teléfono: +82-2-488-6542
  • Correo electrónico: skjung@nunaps.com

Ubicaciones de estudio

  • Corea del Sur
      • Busan, Corea del Sur, 47392
        • Reclutamiento
        • Inje University Busan Paik Hospita
        • Contacto:
          • Eung-Gyu Kim, MD, PhD
      • Chuncheon, Corea del Sur, 24253
        • Reclutamiento
        • Hallym University Chuncheon Sacred Heart Hospital
        • Contacto:
          • Chulho Kim, MD, PhD
      • Daegu, Corea del Sur, 42601
        • Reclutamiento
        • Keimyung University Dongsan Hospital
        • Contacto:
          • Sung Il Sohn, MD, PhD
      • Daegu, Corea del Sur, 42415
        • Aún no reclutando
        • Yeungnam University Medical Center
        • Contacto:
          • Jun Lee, MD, PhD
      • Daegu, Corea del Sur, 41944
        • Aún no reclutando
        • Kyungpook National University Hospital
        • Contacto:
          • Yangha Hwang, MD, PhD
      • Gwangju, Corea del Sur, 61469
        • Reclutamiento
        • Chonnam National University Hospital
        • Contacto:
          • Man Seok Park, MD, PhD
      • Ilsan, Corea del Sur, 10380
        • Reclutamiento
        • Inje University Ilsan Paik Hospital
        • Contacto:
          • Keun-Sik Hong, MD, PhD
      • Jeonju, Corea del Sur, 54907
        • Aún no reclutando
        • Jeonbuk National University Hospital
        • Contacto:
          • Hyun Goo Kang, MD, PhD
      • Seoul, Corea del Sur, 05505
        • Reclutamiento
        • Asan Medical Center
        • Contacto:
          • Jun Young Chang, MD, PhD
      • Seoul, Corea del Sur
        • Reclutamiento
        • Konkuk University Medical Center
        • Contacto:
          • Hahn Young Kim, MD, PhD
      • Ulsan, Corea del Sur, 44033
        • Reclutamiento
        • Ulsan University Hospital
        • Contacto:
          • Jee-Hyun Kwon, MD, PhD
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Corea del Sur, 15355
        • Aún no reclutando
        • Korea University Ansan Hospital
        • Contacto:
          • Jin-Man Jung, MD, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  1. Diagnosed with hemorrhagic or ischemic stroke
  2. At least 3 months have elapsed since stroke onset
  3. History of aphasia resulting from stroke
  4. Aphasia Quotient (AQ) score between 26 and 90 (inclusive) on the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R)
  5. Adults aged 19 years or older
  6. Native Korean speakers
  7. Able to use the investigational device or perform workbook-based training without difficulty
  8. Willing to participate voluntarily and provide written informed consent

Exclusion Criteria:

  1. Diagnosed with language impairment due to causes other than stroke (e.g., traumatic brain injury, brain tumor, or neurodegenerative disease)
  2. History of language impairment due to developmental disorders
  3. Currently receiving speech-language therapy or participating in another clinical trial related to language function
  4. Currently receiving medication for severe psychiatric disorders (e.g., bipolar disorder, major depressive disorder, schizophrenia, alcohol dependence, or substance abuse)
  5. Illiterate individuals
  6. Individuals deemed unsuitable for participation in this study by the investigator
  7. Severe cognitive impairment that would interfere with understanding or performing the study interventions

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: LEXURE
Participants assigned to this arm will receive language training intervention using the LEXURE digital therapeutic (DTx) software.
Dispositivo: LEXURE
Participants will undergo a total of 50 training sessions, conducted 5 times per week for 10 weeks. Each session consists of five training tasks and takes approximately 30 minutes to complete..
Comparador activo: Workbook
Participants assigned to this arm will receive a language therapy workbook and perform structured language exercises as a control intervention.
Conductual: Workbook
Participants will perform language training using a workbook. Training will be conducted 5 times per week for 10 weeks, with each session lasting approximately 30 minutes.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score
Periodo de tiempo: Baseline to Week 10
Change in Aphasia Quotient (AQ) score from baseline to Week 10, measured using the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R). AQ scores range from 0 to 100, with higher scores indicating better language function. Assessments will be conducted by an independent, evaluator-blinded assessor.
Baseline to Week 10

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in K-WAB or PK-WAB-R Spontaneous Speech Score
Periodo de tiempo: Baseline to Week 10
Change from baseline to Week 10 in Spontaneous Speech score measured using the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R). Higher scores indicate better expressive language ability. Assessments will be conducted by an independent, evaluator-blinded assessor.
Baseline to Week 10
Change in K-WAB or PK-WAB-R Auditory Comprehension Score
Periodo de tiempo: Baseline to Week 10
Change from baseline to Week 10 in Auditory Comprehension score measured using the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R). Higher scores indicate better language comprehension ability. Assessments will be conducted by an independent, evaluator-blinded assessor.
Baseline to Week 10
Change in K-WAB or PK-WAB-R Repetition Score
Periodo de tiempo: Baseline to Week 10
Change from baseline to Week 10 in Repetition score measured using the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R). Higher scores indicate better verbal repetition ability. Assessments will be conducted by an independent, evaluator-blinded assessor.
Baseline to Week 10
Change in K-WAB or PK-WAB-R Naming and Word Finding Score
Periodo de tiempo: Baseline to Week 10
Change from baseline to Week 10 in Naming and Word Finding score measured using the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R). Higher scores indicate better lexical retrieval ability. Assessments will be conducted by an independent, evaluator-blinded assessor.
Baseline to Week 10
Mean change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) in the study group
Periodo de tiempo: Baseline to Week 10
Mean change from baseline to Week 10 in Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R) Aphasia Quotient (AQ) score in the study group. The AQ score reflects overall language function. Higher scores indicate better overall language function. Assessments will be conducted by an independent, evaluator-blinded assessor.
Baseline to Week 10

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Nunaps Inc

Investigadores

  • Silla de estudio: Sung Il Sohn, MD, PhD, Keimyung University Dongsan Medical Center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de abril de 2026

Finalización primaria (Estimado)

30 de diciembre de 2026

Finalización del estudio (Estimado)

30 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de abril de 2026

Publicado por primera vez (Actual)

6 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NNS-LEX-01

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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