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Exploratory Evaluation of the Digital Therapeutic Device Zenicom for Subacute Stroke Aphasia

RecruitingPhase 2Ages 19 Years - anyAllSeoul National University Bundang Hospital
NCT07397923 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Clinical Trial Title A Multicenter, Single-Blind, Prospective, Randomized, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of the Digital Therapeutic Device 'Zenicom' for Improving Aphasia in Patients with Subacute Stroke Clinical Trial Objectives To evaluate the efficacy of the digital therapeutic device Zenicom. To evaluate the safety of the digital therapeutic device Zenicom. Clinical Trial Period 6 months from the date of clinical trial plan approval by the Ministry of Food and Drug Safety (MFDS). Target Condition Patients with aphasia resulting from stroke lesions. Target Sample Size Total of 20 subjects (10 in the experimental group and 10 in the control group). Investigational Medical Device Zenicom Clinical Trial Methodology 1. Device Information A) Experimental Device: Digital Speech Therapy Application Group: Performs conventional speech therapy f

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📋 Eligibility rules (as published)
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).
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What it tests

  • Zenicog
  • Conventional Speech Therapy
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Where

3 sites
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Konkuk University Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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