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LEXURE for Post-Stroke Aphasia

12 maj 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

116

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in K-WAB or PK-WAB-R Spontaneous Speech Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Nunaps Inc

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 april 2026

Primärt slutförande (Beräknad)

30 december 2026

Avslutad studie (Beräknad)

30 december 2026

Studieregistreringsdatum

Först inskickad

29 april 2026

Först inskickad som uppfyllde QC-kriterierna

29 april 2026

Första postat (Faktisk)

6 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 maj 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NNS-LEX-01

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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