Digital speech-therapy app Zenicom for subacute post-stroke aphasia in Korean speakers
Evaluation of the Safety and Efficacy of the Digital Therapeutic Device Zenicom for Improving Aphasia in Patients With Subacute Stroke and Aphasia (AQ ≥25), a Multicenter, Single-blind, Prospective, Randomized Exploratory Clinical Trial
This trial will try the Zenicom digital speech-therapy app alongside conventional therapy to see if it helps Korean adults with aphasia after a recent (within 3 months) stroke.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 3 sites (Seongnam-si and 2 other locations) |
| Trial ID | NCT07397923 on ClinicalTrials.gov |
What this trial studies
This multicenter, single-blind, randomized Phase 2 trial will enroll 20 adults with first-ever subacute stroke–related aphasia and randomize them 1:1 to conventional speech therapy alone or conventional therapy plus the Zenicom digital speech-therapy application. The experimental arm receives 30 minutes of conventional speech therapy daily plus an additional digital program during a 2-week treatment period, with language and safety outcomes followed during the overall 6-month trial period. Eligibility requires aphasia confirmed by the PK-WAB-R, Korean as the native language, and onset within 3 months of stroke, and excludes patients with progressive or unstable stroke or other major neuropsychiatric comorbidities. Primary endpoints focus on language function change and device safety to provide exploratory evidence of benefit and tolerability.
Who should consider this trial
Good fit: Adults (≥19 years) with a first-ever subacute stroke (within 3 months) who have aphasia confirmed by PK-WAB-R and are native Korean speakers able to read and consent.
Not a fit: Patients with progressive or hemodynamically unstable stroke, other neurological or major psychiatric disorders, severe visual impairment, illiteracy, or non‑Korean native speakers are unlikely to benefit from this device in this trial.
Why it matters
Potential benefit: If successful, Zenicom could speed or improve language recovery after subacute stroke and offer a scalable, language-tailored adjunct to conventional therapy.
How similar studies have performed: Other studies of computerized or tele-delivered speech therapy have shown modest benefits for post-stroke aphasia, but Zenicom is a language-specific digital therapeutic and remains exploratory in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 19 years or older. * Confirmed by a specialist to have aphasia caused by a stroke lesion. * First-ever subacute stroke (within 3 months of onset) diagnosed via radiological examination (CT, MRI). * Diagnosed with aphasia based on the Speech Assessment (PK-WAB-R). * Whose native language is Korean. Exclusion Criteria: * Have progressive or hemodynamically unstable stroke. * Having other neurological diseases suspected to affect language ability. * Co-morbid major psychiatric disorders requiring continuous medication (e.g., Major Depressive Disorder, Schizophrenia, Bipolar Disorder, Dementia). * Co-morbid major neurogenic diseases other than stroke. * Confirmed history of degenerative neuropathy. * Current or past substance or alcohol use disorder. * Visual impairment (Low vision severity: visual acuity of 0.1-0.3 or lower). * Intellectual disability. * Illiteracy (unable to read and consent).
Where this trial is running
Seongnam-si and 2 other locations
- Seoul National University Bundang Hospital — Seongnam-si, South Korea (Recruiting)
- Konkuk University Medical Center — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Pf. Won Kee Chang, MD, MS
- Email: wkchang@snubh.org
- Phone: +82-31-787-7737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.