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

NCT07397923 | Recruiting Phase 2

• 1 other identifier: E-2506-978-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.Device Information
2. 2.Treatment Duration:
3. 3.Visits:
4. 4.Inclusion Criteria Patients who satisfy all of the following criteria:
5. 5.Exclusion Criteria Patients meeting any of the following criteria will be excluded:
6. 6.Suspension Criteria
7. 7.Dropout Criteria
8. 8.Primary Efficacy Endpoint
9. 9.Secondary Efficacy Endpoints

Conditions

Aphasia; Stroke

Keywords

digital therapeutics; aphasia treatment; subacute stroke; korean language

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• K-BNT (Korean version of Boston Naming Test)

  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)

  T-1: Screening T0: Baseline T1: EOT(end of treatment: 2week after)

• Adverse Event

  T1: EOT(end of treatment: 2week after)

Study Arms (2)

Experimental Group: Conventional Speech Therapy + Digital Speech Therapy

EXPERIMENTAL

Performs conventional speech therapy for 30 minutes daily + additional digital speech therapy program during the 2-week treatment period.

Device: Zenicog; Other: Conventional Speech Therapy

Control Group: Conventional Speech Therapy

ACTIVE COMPARATOR

Performs only conventional speech therapy for 30 minutes daily during the 2-week treatment period.

Other: Conventional Speech Therapy

Interventions

Zenicog DEVICE

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

Experimental Group: Conventional Speech Therapy + Digital Speech Therapy

Conventional Speech Therapy OTHER

Conventional speech therapy is provided for 30 minutes daily in face-to-face by a Speech-Language-Pathologist

Control Group: Conventional Speech Therapy; Experimental Group: Conventional Speech Therapy + Digital Speech Therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Konkuk University Hospital: collaborator
• Samsung Medical Center: collaborator

Study Sites (3)

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

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Pf. Won Kee Chang, MD, MS

CONTACT

+82-31-787-7737; wkchang@snubh.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A Multi-center randomized controlled trial

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

KR (3)