LEXURE for Post-Stroke Aphasia

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.

Study Overview

• Status: Recruiting
• Conditions: Aphasia
• Intervention / Treatment: Device: LEXURE; Behavioral: Workbook

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.

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suekyung Jung; Phone Number: +82-2-488-6542; Email: skjung@nunaps.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEXURE; Participants assigned to this arm will receive language training intervention using the LEXURE digital therapeutic (DTx) software.	Device: 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..
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 10
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.	Baseline to Week 10
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.	Baseline to Week 10
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.	Baseline to Week 10
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.	Baseline to Week 10

Collaborators and Investigators

• Sponsor: Nunaps Inc
• Investigators: Study Chair: Sung Il Sohn, MD, PhD, Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: stroke; aphasia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Aphasia
• Other Study ID Numbers: NNS-LEX-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No