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首尔大学盆唐医院Exploratory Evaluation of the Digital Therapeutic Device Zenicom for Subacute Stroke Aphasia II期 20 随机化 医疗器械 数字疗法
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临床试验NCT07397923旨在研究治疗，主要针对失语症，中风。这是一项II期 干预性研究试验，目前试验状态为招募中。试验始于2025年12月10日，计划招募20名患者。该研究由首尔大学盆唐医院主导，预计于2026年8月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月10日。
简要概括
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 Perio...
显示更多官方标题
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
疾病
失语症中风其他研究标识符
- E-2506-978-003
NCT编号
实际开始日期
2025-12-10
最近更新发布
2026-02-10
预计完成日期
2026-08-31
计划入组人数
20
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
招募中
关键词
digital therapeutics
aphasia treatment
subacute stroke
korean language
aphasia treatment
subacute stroke
korean language
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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. | 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,...显示更多 Conventional Speech Therapy Conventional speech therapy is provided for 30 minutes daily in face-to-face by a Speech-Language-Pathologist |
阳性对照Control Group: Conventional Speech Therapy Performs only conventional speech therapy for 30 minutes daily during the 2-week treatment period. | Conventional Speech Therapy Conventional speech therapy is provided for 30 minutes daily in face-to-face by a Speech-Language-Pathologist |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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) |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
19 Years
适龄性别
全部
- 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.
- 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).
首尔大学盆唐医院90 个活跃的临床试验可供探索- Konkuk University Hospital
- Samsung Medical Center
研究责任方
Won Kee Chang, 主要研究者, Assistant Professor, Seoul National University Bundang Hospital
研究中心联系人
联系人: Pf. Won Kee Chang, MD, MS, +82-31-787-7737, [email protected]
3 位于 1 个国家/地区的研究中心
Seoul National University Bundang Hospital, Seongnam-si, South Korea
招募中
Konkuk University Medical Center, Seoul, South Korea
招募中
Samsung Medical Center, Seoul, South Korea
招募中