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

Nunaps

Status: Enrolling

Conditions: Aphasia

Treatments: Behavioral: Workbook; Device: LEXURE

Study type: Interventional

Funder types: Industry

Identifiers

NCT07570264

NNS-LEX-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

LEXURE

Experimental group

Description:

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

Treatment:

Device: LEXURE

Workbook

Active Comparator group

Description:

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

Treatment:

Behavioral: Workbook