2012-08-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/646359摘要：背景及研究目的 中風後患側上肢動作偏癱是中風最常見的後遺症之ㄧ，嚴重影響中風病人之功能及生活品質。「經顱直流電刺激術(transcranial direct current stimulation, tDCS)」可用於刺 激中風病患患側大腦皮質活性或抑制其健側大腦皮質活性，在臨床復健訓練的同時調控 大腦可塑性，強化患側大腦復原，進而提升復健訓練成效。tDCS 為非侵入性刺激，安 全且副作用低，臨床使用便利，深具中風後動作偏癱治療之潛力。然而 tDCS 對於中風 病人上肢動作/功能訓練之加成療效，因為欠缺大型且長期之隨機控制試驗，以至於療效 與機制仍不清。任務導向訓練(task-oriented approach)為易於臨床執行之復健訓練，因此 本研究將探究 tDCS 結合任務導向訓練對於慢性中風病人上肢功能之立即及長期成效。方法本 3 年研究為二階段雙盲設計之隨機分組控制實驗。初步研究（前 1.5 年）將徵召80 位單側單次偏癱之慢性中風患者隨機分配於實驗組與對照組，實驗組個案將接受tDCS 結合任務導向上肢功能訓練，每週 3 次、每次 30 分鐘、為期 8 週。tDCS 刺激包 含抑制健側大腦皮質之興奮以及激發患側大腦皮質之活性。對照組個案接受假性 tDCS 刺激(sham tDCS)以及任務導向上肢功能訓練，次數與分量同實驗組。主要療效指標包 含：上肢動作及功能、日常生活功能與生活品質評量。而為探討 tDCS 加成療效對大腦 塑性之影響，將以功能性磁振造影(functional Magnetic Resonance Imaging, fMRI)、結構 性 MRI 以及動作誘發電位(motor evoked potentials, MEPs)等影像技術驗證之。所有個案 接受 3 次療效評量（訓練前、訓練後及訓練後 6 個月），其中每組 15 人接受 3 次影像 學檢查。進階研究（後 1.5 年）於第 2 年中開始，探討密集與間隔給予 tDCS 刺激之加成療 效差異。將依據初步研究療效較佳的個案當成篩選條件，以徵召 80 位單側單次偏癱之慢性中風患者隨機分配於 2 組：(1)每週 3 次，每次 30 分鐘；(2) 每週 5 次，每次 30 分鐘。所有個案均接受 24 次之 tDCS 結合任務導向上肢功能訓練，及 3 次療效評量（訓 練前、訓練後及訓練後 6 個月），同時每組中 15 人接受 3 次影像學檢查，以確認「tDCS 結合任務導向上肢功能訓練」之最佳且適用於臨床實境的治療模式。預期結果與貢獻本計畫將有助於確認 tDCS 結合任務導向上肢功能訓練對於慢性中風病人上肢復健 之成效、最適合之治療對象及治療密集度。透過 fMRI 與 TMS 所得之指標亦可確認 tDCS 活化之大腦皮質區域，是否確實造成大腦皮質之重組，並協助進一步探討其復原 機轉。<br> Abstract: Background and purposeImpaired upper extremity motor function is one of the most common sequels in patients with stroke. It influences the daily function and quality of life seriously. Transcranial Direct Current Stimulation (tDCS) can simultaneously stimulate the affected and inhibit the unaffected cerebral cortex activation. It is non-invasive, safe, with low side effects, and convenient for clinical use.Its characteristics help to adjust and regulate the brain plasticity and promote the recovery of the affected hemisphere during rehabilitation training, having extensive potentiality to enhance the treatment effect for patients with stroke. Thetask-oriented training is a client-centered approach to improve patients’ function. It is hypothesized that the “tDCS combined task-oriented training” has greater potential to facilitate patients’ recovery than each of them. However, since the lack of large-sample and long-term randomized controlled trials, the treatment effect and mechanism of this intervention is still unclear. Therefore, this study will investigate the immediate andlong-term effects of the “tDCS combined task-oriented training” on the upper extremity function in patients with chronic stroke.MethodsThis three-year double-blinded, randomized controlled trial study will be divided into two parts: preliminary and advanced research. In preliminary research (the preceding 1.5 years), 80 participants post-stroke at least 6 months will be recruited and assigned randomly into 2 groups. The participants of experiment group will receive 30-minute “tDCS combined task-oriented training” (3 times a week for 8 weeks). tDCS stimulation includes inhibiting unaffected and facilitating affected cerebral cortex excitability. The participants of control group will receive “sham-tDCS combined task-oriented training” with the same intensity and duration as experiment group. Primary outcome indicators include upper extremity function, activities of daily living function, quality of life.To investigate the addition effect of tDCS on the brain plasticity, we will use functional magnetic resonance imaging (fMRI), structural MRI and transcranial magnetic stimulation (TMS) to examine. All the subjects will be assessed 3 times (i.e., prior to the intervention, after the intervention, and 6 months post experiment) and 15 participants /group will receive 3times of imaging examination.Advanced research (the following 1.5 years) will begin in the 2nd year to investigate the impact of tDCS stimulation intervals, during which 80 participants will be recruited. The inclusion criteria will be according to the preliminary research with better treatment effect. The participants will be assigned randomly to the following 2 groups: (1) 30 minutes/time, 3 times/week; and (2) 30 minutes/time, 5 times/week. All participants will receive “tDCS combined task-oriented training” for 24 times, be assessed 3 times (i.e., prior to the intervention, after the intervention, and 6 months post experiment) and 15 participants/group will receive 3 times ofimaging examination to verify the best implement method of the “tDCS combined task-oriented training”.Anticipatory results and contributionsThe results of this study will help to confirm the effectiveness, stimulation intervals of the “tDCS combined task-oriented training” on upper extremity functional recovery when applied to chronic patients with stroke. In addition, fMRI and TMS will provide the evidence of individual cerebral reactivation/reorganization and further assist in realizing and investigating the recovery mechanism.中風復健腦刺激任務導向訓練strokerehabilitationbrain stimulationtask-oriented training