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LEXURE for Post-Stroke Aphasia

12. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

116

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Sør -Korea
      • Busan, Sør -Korea, 47392
        • Rekruttering
        • Inje University Busan Paik Hospita
        • Ta kontakt med:
          • Eung-Gyu Kim, MD, PhD
      • Chuncheon, Sør -Korea, 24253
        • Rekruttering
        • Hallym University Chuncheon Sacred Heart Hospital
        • Ta kontakt med:
          • Chulho Kim, MD, PhD
      • Daegu, Sør -Korea, 42601
        • Rekruttering
        • Keimyung University Dongsan Hospital
        • Ta kontakt med:
          • Sung Il Sohn, MD, PhD
      • Daegu, Sør -Korea, 42415
        • Har ikke rekruttert ennå
        • Yeungnam University Medical Center
        • Ta kontakt med:
          • Jun Lee, MD, PhD
      • Daegu, Sør -Korea, 41944
        • Har ikke rekruttert ennå
        • Kyungpook National University Hospital
        • Ta kontakt med:
          • Yangha Hwang, MD, PhD
      • Gwangju, Sør -Korea, 61469
        • Rekruttering
        • Chonnam National University Hospital
        • Ta kontakt med:
          • Man Seok Park, MD, PhD
      • Ilsan, Sør -Korea, 10380
        • Rekruttering
        • Inje University Ilsan Paik Hospital
        • Ta kontakt med:
          • Keun-Sik Hong, MD, PhD
      • Jeonju, Sør -Korea, 54907
        • Har ikke rekruttert ennå
        • Jeonbuk National University Hospital
        • Ta kontakt med:
          • Hyun Goo Kang, MD, PhD
      • Seoul, Sør -Korea, 05505
        • Rekruttering
        • Asan Medical Center
        • Ta kontakt med:
          • Jun Young Chang, MD, PhD
      • Seoul, Sør -Korea
        • Rekruttering
        • Konkuk University Medical Center
        • Ta kontakt med:
          • Hahn Young Kim, MD, PhD
      • Ulsan, Sør -Korea, 44033
        • Rekruttering
        • Ulsan University Hospital
        • Ta kontakt med:
          • Jee-Hyun Kwon, MD, PhD
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Sør -Korea, 15355
        • Har ikke rekruttert ennå
        • Korea University Ansan Hospital
        • Ta kontakt med:
          • Jin-Man Jung, MD, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: LEXURE
Participants assigned to this arm will receive language training intervention using the LEXURE digital therapeutic (DTx) software.
Enhet: 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..
Aktiv komparator: Workbook
Participants assigned to this arm will receive a language therapy workbook and perform structured language exercises as a control intervention.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in K-WAB or PK-WAB-R Spontaneous Speech Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nunaps Inc

Etterforskere

  • Studiestol: Sung Il Sohn, MD, PhD, Keimyung University Dongsan Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. april 2026

Primær fullføring (Antatt)

30. desember 2026

Studiet fullført (Antatt)

30. desember 2026

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

29. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NNS-LEX-01

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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