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RecruitingNCT07570264Updated May 14, 2026

LEXURE for Post-Stroke Aphasia

An interventional study of LEXURE and Workbook in Aphasia, sponsored by Nunaps Inc. Recruiting at 12 sites in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Nunaps Inc · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Aphasia

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Keywords

  • aphasia
  • stroke
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
116 participants (estimated)

Study arms

  • Experimental
    LEXURE

    Participants assigned to this arm will receive language training intervention using the LEXURE digital therapeutic (DTx) software.

    Device: LEXURE

  • Active comparator
    Workbook

    Participants assigned to this arm will receive a language therapy workbook and perform structured language exercises as a control intervention.

    Behavioral: Workbook

Interventions

  • DeviceLEXURE

    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..

  • BehavioralWorkbook

    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.

05

What researchers measure

Primary outcomes

  1. Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score

    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.

    Time frame: Baseline to Week 10

Secondary outcomes

  1. Change in K-WAB or PK-WAB-R Spontaneous Speech Score

    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.

    Time frame: Baseline to Week 10

  2. Change in K-WAB or PK-WAB-R Auditory Comprehension Score

    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.

    Time frame: Baseline to Week 10

  3. Change in K-WAB or PK-WAB-R Repetition Score

    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.

    Time frame: Baseline to Week 10

  4. Change in K-WAB or PK-WAB-R Naming and Word Finding Score

    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.

    Time frame: Baseline to Week 10

  5. Mean change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) in the study group

    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.

    Time frame: Baseline to Week 10

06

Study locations

8 of 12 sites recruiting
  • Korea University Ansan Hospital
    Ansan, Gyeonggi-do 15355, South Korea
    • Jin-Man Jung, MD, PhD · Contact
    Not yet recruiting
  • Inje University Busan Paik Hospita
    Busan, 47392, South Korea
    • Eung-Gyu Kim, MD, PhD · Contact
    Recruiting
  • Hallym University Chuncheon Sacred Heart Hospital
    Chuncheon, 24253, South Korea
    • Chulho Kim, MD, PhD · Contact
    Recruiting
  • Kyungpook National University Hospital
    Daegu, 41944, South Korea
    • Yangha Hwang, MD, PhD · Contact
    Not yet recruiting
  • Yeungnam University Medical Center
    Daegu, 42415, South Korea
    • Jun Lee, MD, PhD · Contact
    Not yet recruiting
  • Keimyung University Dongsan Hospital
    Daegu, 42601, South Korea
    • Sung Il Sohn, MD, PhD · Contact
    Recruiting
  • Chonnam National University Hospital
    Gwangju, 61469, South Korea
    • Man Seok Park, MD, PhD · Contact
    Recruiting
  • Inje University Ilsan Paik Hospital
    Ilsan, 10380, South Korea
    • Keun-Sik Hong, MD, PhD · Contact
    Recruiting
  • Jeonbuk National University Hospital
    Jeonju, 54907, South Korea
    • Hyun Goo Kang, MD, PhD · Contact
    Not yet recruiting
  • Asan Medical Center
    Seoul, 05505, South Korea
    • Jun Young Chang, MD, PhD · Contact
    Recruiting
  • Konkuk University Medical Center
    Seoul, South Korea
    • Hahn Young Kim, MD, PhD · Contact
    Recruiting
  • Ulsan University Hospital
    Ulsan, 44033, South Korea
    • Jee-Hyun Kwon, MD, PhD · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT07570264
Lead sponsor
Nunaps Inc
Responsible party
Sponsor
First posted
May 6, 2026
Start date
Apr 16, 2026
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
May 14, 2026

Study contacts

Suekyung Jung
Contact
skjung@nunaps.com
+82-2-488-6542
Sung Il Sohn, MD, PhD
study chair · Keimyung University Dongsan Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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