Study on the Efficacy and Neural Mechanisms of Transcranial Direct Current Stimulation Targeting the Supplementary Motor Area for the Treatment of Subacute Post-stroke Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Aphasia quotient (AQ)
研究概览
简要总结
This study aims to investigate the efficacy of transcranial direct current stimulation (tDCS) in patients with post-stroke aphasia (PSA) and to explore its potential neural mechanisms. The study will recruit PSA patients and provide them with 14 tDCS sessions over 7 days, along with speech therapy. Language Behavior Scale scores and resting-state functional MRI scans will be collected before and after the intervention. In addition, a retrospective comparison will be conducted of language function and resting-state fMRI changes in a group of PSA patients who received only speech therapy; these patients did not undergo any physical intervention but received only speech therapy. Changes in Language Behavior Scale scores and functional connectivity (FC) before and after treatment in the speech therapy-only group will be analyzed and compared with those in the tDCS intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be between 18 and 80 years of age
- •First stroke in the left hemisphere
- •Stroke onset within the past 12 weeks
- •Native Chinese speakers who were able to communicate normally prior to onset
- •Diagnosed with aphasia using the ABC scale
- •Right-handed
- •Informed consent obtained from the patient and family members
排除标准
- •Time since stroke onset exceeds 12 weeks
- •History of psychiatric or neurological disorders
- •History of surgery for severe head trauma, brain tumors, or brain abscesses
- •Severe articulation disorders
- •Claustrophobia or implants incompatible with MRI
- •Inability to cooperate with language scale testing or fMRI scanning
- •History of previous stroke
研究组 & 干预措施
The speech-language therapy group
The speech-language therapy group received only 7 days of speech-language therapy.
tDCS group
PSA patients enrolled in the tDCS group received tDCS treatment twice daily for 7 consecutive days, along with 7 days of speech-language therapy. The current intensity was 2 mA, and each treatment session lasted 20 minutes.
干预措施: transcranial direct current stimulation (Other)
结局指标
主要结局
Aphasia quotient (AQ)
时间窗: Baseline, immediately after all interventions have ended
The Aphasia Battery of Chinese (ABC) is a standardized Chinese adaptation of the Western Aphasia Battery (WAB). The Aphasia Quotient (AQ) is a composite score that reflects the overall severity of language impairment. The AQ score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better language function (i.e., less severe impairment).
次要结局
- rs-fMRI(Baseline, immediately after all interventions have ended)
研究者
Panpan Hu, MD
Head of Neurology Department, The First Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Anhui Medical University