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

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 for 30 minutes daily + additional digital speech therapy program during the 2-week treatment period. B) Control Device: Conventional Speech Therapy Group: Performs only conventional speech therapy for 30 minutes daily during the 2-week treatment period. 2. Treatment Duration: Total 2 weeks (10 working days; total usage of 600 minutes or more). 3. Visits: Total of 3 visits including outpatient and therapy room visits. Visit 1 (T-1): Screening Visit 2 (T0): Baseline and Treatment initiation Visit 3 (T1): Post-treatment assessment Inclusion and Exclusion Criteria 1. Inclusion Cri…

This description comes directly from the study's public registry record.

Pf. Won Kee Chang, MD, MS  ·  +82-31-787-7737  ·  wkchang@snubh.org

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