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

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

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 Criteria Patients who satisfy all of the following criteria:

   Adults aged 19 years or older.

   Patients confirmed by a specialist to have aphasia caused by a stroke lesion.

   Patients with first-ever subacute stroke (within 3 months of onset) diagnosed via radiological examination (CT, MRI).

   Patients diagnosed with aphasia based on the Speech Assessment (PK-WAB-R).

   Patients whose native language is Korean.

   Patients capable of voluntarily consenting to the study.

2. Exclusion Criteria Patients meeting any of the following criteria will be excluded:

Progressive or hemodynamically unstable stroke.

Patients with 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).

Patients deemed inappropriate for participation for other reasons.

Refusal to participate in the study.

Suspension and Dropout Criteria

1. Suspension Criteria

   If circumstances observed during the trial make it judged unreasonable to continue the study.

   Occurrence of Serious Adverse Events (SAE).

2. Dropout Criteria

The subject requests to stop participation or withdraws consent during the trial.

The investigator determines that the subject cannot continue the trial due to adverse events (e.g., headache, eye fatigue, nausea, dizziness, etc.).

The subject arbitrarily takes medication expected to affect the comparative evaluation of the investigational device during the trial.

The dosage of medication that may affect the comparative evaluation of the investigational device is changed during the trial.

Discovery of major protocol violations, such as violation of inclusion/exclusion criteria.

The subject fails to attend scheduled visits and cannot be contacted.

The subject fails to perform the digital speech therapy program for a total of 600 minutes or more.

The investigator determines that the trial should be stopped for other reasons.

Endpoints (Outcome Measures)

1. Primary Efficacy Endpoint

   Change in PK-WAB-R scores between T0 and T1 between groups.

2. Secondary Efficacy Endpoints

Change in K-BNT scores between T0 and T1 between groups.

Change in K-SAQOL-12 scores between T0 and T1 between groups.

Statistical Analysis Methods To evaluate the change in PK-WAB-R between T0 and T1 between groups, an independent two-sample test will be used. Depending on the distribution of the change, a parametric method (Student's t-test) or a non-parametric method (Mann-Whitney U test) will be selected and applied.

To evaluate the changes in K-BNT and K-SAQOL-12 between T0 and T1 between groups, an independent two-sample test will be used. Depending on the distribution of the change, a parametric method (Student's t-test) or a non-parametric method (Mann-Whitney U test) will be selected and applied.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Aphasia
• Intervention / Treatment: Device: Zenicog; Other: Conventional Speech Therapy

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pf. Won Kee Chang, MD, MS; Phone Number: +82-31-787-7737; Email: wkchang@snubh.org

Study Locations

• South Korea
  • Seongnam-si, South Korea
    • Recruiting
    • Seoul National University Bundang Hospital
  • Seoul, South Korea
    • Recruiting
    • Samsung Medical Center
  • Seoul, South Korea
    • Recruiting
    • Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group: Conventional Speech Therapy + Digital Speech Therapy; Performs conventional speech therapy for 30 minutes daily + additional digital speech therapy program during the 2-week treatment period.	Device: Zenicog; This medical device is a Software as a Medical Device (SaMD) consisting of a patient application and a patient management web portal for medical staff. It is designed to provide personalized digital therapeutic content to patients with aphasia for the alleviation and improvement of language function symptoms. The therapeutic mechanism of this device is speech therapy delivered through a personalized content program, intended to improve the language function of aphasia patients. The device's treatment program alleviates and improves language function based on Stimulation-Facilitation Treatment and Functional Communication techniques, which are aphasia speech therapy methods recommended by the Korean Clinical Practice Guidelines for Stroke Rehabilitation (Brain & Neurorehabilitation). The training recommendation model applied to this device provides personalized training content based on the subject's performance characteristics and proficiency level. The analyzed performance character; Other: Conventional Speech Therapy; Conventional speech therapy is provided for 30 minutes daily in face-to-face by a Speech-Language-Pathologist
Active Comparator: Control Group: Conventional Speech Therapy; Performs only conventional speech therapy for 30 minutes daily during the 2-week treatment period.	Other: Conventional Speech Therapy; Conventional speech therapy is provided for 30 minutes daily in face-to-face by a Speech-Language-Pathologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK-WAB AQ(Korean Version of PK-WAB-R AQ)	The Aphasia Quotient (AQ) is a weighted composite score derived from the Western Aphasia Battery (WAB) (or its Korean adaptation, PK-WAB-R). It serves as a primary quantitative index of the severity of spoken language deficits in patients with aphasia.	T-1: Screening T0: Baseline T1: EOT(end of treatment: 2week after)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
K-BNT (Korean version of Boston Naming Test)	A standardized neuropsychological assessment tool designed to evaluate confrontation naming ability (lexical retrieval) in individuals with cognitive impairments. It is the linguistically and culturally adapted version of the widely used Boston Naming Test (BNT).	T-1: Screening T0: Baseline T1: EOT(end of treatment: 2week after)
K-SAQoL-12 (Korean version of Stroke and Aphasia Quality of Life Scale-12)	K-SAQoL-12 is the shortened, validated Korean version of the Stroke and Aphasia Quality of Life Scale-39 (SAQoL-39). It is a patient-reported outcome measure (PROM) designed to assess Health-Related Quality of Life (HRQoL) specifically in stroke survivors with aphasia.	T-1: Screening T0: Baseline T1: EOT(end of treatment: 2week after)
Adverse Event	Any adverse event occurred during intervention	T1: EOT(end of treatment: 2week after)

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Samsung Medical Center; Konkuk University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: digital therapeutics; subacute stroke; aphasia treatment; korean language
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Aphasia
• Other Study ID Numbers: E-2506-978-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No