LEXURE for Post-Stroke Aphasia: A Randomized, Evaluator-Blinded, Confirmatory Trial

NCT07570264 | Recruiting

• 1 other identifier: NNS-LEX-01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Aphasia

Keywords

aphasia; stroke

Outcome Measures

Primary Outcomes (1)

• Change in K-WAB/PK-WAB-R AQ

  change in Aphasia Quotient (AQ) score from baseline to Week 10, measured using the K-WAB/PK-WAB-R. The AQ score reflects overall language function, Assessments will be conducted by an independent, evaluator-blinded assessor.

  Baseline to Week 10

Secondary Outcomes (5)

• Change in K-WAB/PK-WAB-R Spontaneous Speech Score

  Baseline to Week 10

• Change in K-WAB/PK-WAB-R Auditory Comprehension Score

  Baseline to Week 10

• Change in K-WAB/PK-WAB-R Repetition Score

  Baseline to Week 10

• Change in K-WAB/PK-WAB-R Naming and Word Finding Score

  Baseline to Week 10

• Mean change in K-WAB/PK-WAB-R Aphasia Quotient (AQ) in the study group

  Baseline to Week 10

Study Arms (2)

LEXURE

EXPERIMENTAL

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

Device: LEXURE

Workbook

ACTIVE COMPARATOR

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

Behavioral: Workbook

Interventions

LEXURE DEVICE

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..

LEXURE

Workbook BEHAVIORAL

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.

Workbook

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with hemorrhagic or ischemic stroke
• At least 3 months have elapsed since stroke onset
• History of aphasia resulting from stroke
• 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)
• Adults aged 19 years or older
• Native Korean speakers
• Able to use the investigational device or perform workbook-based training without difficulty
• Willing to participate voluntarily and provide written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Nunaps Inc: lead

Study Sites (12)

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 15355, South Korea

NOT YET RECRUITING

Inje University Busan Paik Hospita

Busan, 47392, South Korea

RECRUITING

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, 24253, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, 41944, South Korea

NOT YET RECRUITING

Yeungnam University Medical Center

Daegu, 42415, South Korea

NOT YET RECRUITING

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, 61469, South Korea

RECRUITING

Inje University Ilsan Paik Hospital

Ilsan, 10380, South Korea

RECRUITING

Jeonbuk National University Hospital

Jeonju, 54907, South Korea

NOT YET RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Konkuk University Medical Center

Seoul, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, 44033, South Korea

RECRUITING

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sung Il Sohn, MD, PhD

  Keimyung University Dongsan Medical Center

  STUDY CHAIR

Central Study Contacts

Suekyung Jung

CONTACT

+82-2-488-6542; skjung@nunaps.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

KR (12)