AphasiaNCT07570264
LEXURE for Post-Stroke Aphasia
A study testing LEXURE and Workbook in people with Aphasia, run by Nunaps Inc at 12 sites in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphasia
- What is being tested?
- LEXURE and Workbook
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 16 Apr 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
South Korea12 sites, 12 recruiting
- Not yet recruiting
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355
Jin-Man Jung, MD, PhD
- Recruiting
Inje University Busan Paik Hospita
Busan, 47392
Eung-Gyu Kim, MD, PhD
- Recruiting
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, 24253
Chulho Kim, MD, PhD
- Not yet recruiting
Kyungpook National University Hospital
Daegu, 41944
Yangha Hwang, MD, PhD
- Not yet recruiting
Yeungnam University Medical Center
Daegu, 42415
Jun Lee, MD, PhD
- Recruiting
Keimyung University Dongsan Hospital
Daegu, 42601
Sung Il Sohn, MD, PhD
- Recruiting
Chonnam National University Hospital
Gwangju, 61469
Man Seok Park, MD, PhD
- Recruiting
Inje University Ilsan Paik Hospital
Ilsan, 10380
Keun-Sik Hong, MD, PhD
- Not yet recruiting
Jeonbuk National University Hospital
Jeonju, 54907
Hyun Goo Kang, MD, PhD
- Recruiting
Asan Medical Center
Seoul, 05505
Jun Young Chang, MD, PhD
- Recruiting
Konkuk University Medical Center
Seoul
Hahn Young Kim, MD, PhD
- Recruiting
Ulsan University Hospital
Ulsan, 44033
Jee-Hyun Kwon, MD, PhD
About this study
Official title: 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.
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.
- Conditions
- Aphasia
- Being tested
- LEXURE, Workbook
- Keywords
- aphasia, stroke
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEXUREDevice
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..
WorkbookBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| LEXURE | Experimental | Participants assigned to this arm will receive language training intervention using the LEXURE digital therapeutic (DTx) software. Receives: 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. Receives: Behavioral: Workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 10
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start16 Apr 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nunaps Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung Il Sohn, MD, PhD, Study chair, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570264
- Sponsor's protocol ID
- NNS-LEX-01
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07570264
- Acronym / sponsor ID
- NNS-LEX-01
- Conditions
- Aphasia
- Keywords
- aphasia, stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Nunaps IncIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEXURE | Experimental | Device: LEXUREParticipants assigned to this arm will receive language training intervention using the LEXURE digital therapeutic (DTx) software. |
| Workbook | Active comparator | Behavioral: WorkbookParticipants assigned to this arm will receive a language therapy workbook and perform structured language exercises as a control intervention. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEXUREParticipants 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.. | Device | LEXURE |
| WorkbookParticipants 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. | Behavioural | Workbook |
Primary outcome
Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score
Time frame: 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.
5 secondary outcomes
Change in K-WAB or PK-WAB-R Spontaneous Speech Score
Time frame: Baseline to Week 10
Change in K-WAB or PK-WAB-R Auditory Comprehension Score
Time frame: Baseline to Week 10
Change in K-WAB or PK-WAB-R Repetition Score
Time frame: Baseline to Week 10
Change in K-WAB or PK-WAB-R Naming and Word Finding Score
Time frame: Baseline to Week 10
Mean change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) in the study group
Time frame: Baseline to Week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sung Il Sohn, MD, PhD study chair
Keimyung University Dongsan Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEXURE and Workbook in people with Aphasia, run by Nunaps Inc at 12 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suekyung Jung (+82-2-488-6542, skjung@nunaps.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score (time frame: Baseline to Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.