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【ChiCTR2500098068】Exploring the augmentative effects and mechanisms of integrating computerized cognitive training with transcranial magnetic stimulation in late-life depression: a proof-of-concept randomized controlled trial

基本信息
登记号

ChiCTR2500098068

试验状态

尚未开始

药物名称

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药物类型

/

规范名称

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首次公示信息日的期

2025-03-03

临床申请受理号

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靶点

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适应症

Depression

试验通俗题目

Exploring the augmentative effects and mechanisms of integrating computerized cognitive training with transcranial magnetic stimulation in late-life depression: a proof-of-concept randomized controlled trial

试验专业题目

Exploring the augmentative effects and mechanisms of integrating computerized cognitive training with transcranial magnetic stimulation in late-life depression: a proof-of-concept randomized controlled trial

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

1. The primary objective is to examine the effect of combined rTMS and CCT on changes in depressive symptoms. 2. The secondary objective is to examine the effect of combined rTMS and CCT on changes in mood, cognition, level of functioning, functional brain networks, cortical excitability, and serum BDNF levels.

试验分类
试验类型

随机平行对照

试验分期

其它

随机化

Participants will be randomly assigned to either the intervention or control group in a 1:1 ratio using a central computer-generated random number sequence.

盲法

No one, except the RA who sets up the CCT station, will know the group assignments. Participants will not know their group or the exact CCT setting, and they will be asked not to discuss their treatment with others. The rTMS operator and the RA who prepares the CCT station will not assess outcomes. Outcome assessors will be blinded to group assignments and not involved in intervention delivery.

试验项目经费来源

Research Grants Council

试验范围

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目标入组人数

60

实际入组人数

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第一例入组时间

2025-03-01

试验终止时间

2028-12-31

是否属于一致性

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入选标准

Ethnic Chinese; aged 55 to 75 years; right-handed; living at home; having a primary diagnosis of major depressive disorder (single or recurrent episodes without psychotic features) based on DSM-5 criteria; current episode scoring >17 in the Hong Kong Chinese version of the 17-item Hamilton Rating Scale for Depression (HAM-D), with cognitive symptoms [Item 8 in HAM-D (slowness of thought and speech, impaired ability to concentrate) scoring ≥2]; not responding to an adequate dose of an antidepressant; and having received a stable antidepressant regimen for at least 4 weeks before joining this trial.;

排除标准

Alcohol or substance abuse; bipolar disorder; any psychotic disorder or current psychotic symptoms; dementia; active suicidal ideation; anxiety disorder; personality disorder; mental disorder due to organic cause; neurological disorders (Parkinson’s disease, stroke, brain tumor); and unstable physical illness. Individuals identified with these conditions will be excluded and referred to the Hospital Authority for further management. Other exclusion criteria are: history of seizure or epilepsy; contraindications to magnetic resonance imaging (MRI); metallic implants in cephalic region (including aneurysm clips, shuts, stimulators, cochlear implant, or electrodes); history of receiving non-invasive brain stimulation (TMS, tDCS, tACS, etc.), electroconvulsive therapy, cognitive training, or psychological intervention in the past 6 months; refusing blood taking or MRI; or having language barrier or communication impairments (poor vision and hearing despite correction).;

研究者信息
研究负责人姓名
试验机构

The Chinese University of Hong Kong

研究负责人电话
研究负责人邮箱
研究负责人邮编

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联系人通讯地址
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