Motor cortex stimulation for the enhancement of recovery from stroke: A prospective, multicenter safety study
Motor cortex stimulation for the enhancement of recovery from stroke: A prospective, multicenter safety study
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DOI：
10.1227/01.neu.0000197100.63931.04
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发表时间：
2006-03-01
期刊：
影响因子：
4.8
通讯作者：
Cramer, SC
中科院分区：
文献类型：
--
作者：
Brown, JA;Lutsep, HL;Cramer, SC
目的：功能性磁共振成像和经颅磁刺激研究表明，人类皮层具有神经可塑性。在大鼠和猴子身上进行的临床前研究表明，运动皮质刺激可以增强脑卒中后的可塑性并促进恢复。本研究评估了阈下硬膜外皮质刺激与强化康复治疗同时进行的安全性和初步疗效，同时使用一种研究性装置治疗慢性偏瘫卒中患者。方法：这是一项前瞻性、多中心、非盲法试验，将患者随机分为有或无皮质刺激的康复组。年龄在20岁到75岁之间且至少4个月前发生过缺血性中风导致手臂持续中度无力的患者被纳入研究对象。功能磁共振成像在手术前定位手部运动功能，放置硬膜外皮质电极。两组均接受3周的康复治疗，然后取出电极。在基线、治疗期间以及术后1、4、8和12周获得结果测量。结果：10例患者随机化；6名患者接受手术，4名患者作为对照组。无患者死亡、神经系统恶化或癫痫发作。有两例感染与协议无关。在完成治疗的8例患者中，刺激加康复组上肢Fugl-Meyer评分（P = 0.003）和脑卒中影响量表手功能评分（P = 0.001）显著优于对照组。结论：脑皮层刺激增强脑卒中恢复的技术具有良好的耐受性和安全性。
OBJECTIVE: Functional magnetic resonance imaging and transcranial magnetic stimulation studies suggest that human cortex shows evidence of neuroplasticity. Preclinical studies in rats and monkeys suggest that motor cortical stimulation can enhance plasticity and improve recovery after stroke. This study assesses the safety and preliminary efficacy of targeted subthreshold epidural cortical stimulation delivered concurrently with intensive rehabilitation therapy while using an investigational device in patients with chronic hemiparetic stroke.METHODS: This is a prospective, multicenter, and nonblinded trial randomizing patients to rehabilitation with or without cortical stimulation. Patients aged 20 to 75 years who had had an ischemic stroke at least 4 months previously causing persistent moderate weakness of the arm were included. Functional magnetic resonance imaging localized hand motor function before surgery to place an epidural cortical electrode. Both groups then underwent rehabilitation for 3 weeks after which the electrode was removed. Outcome measures were obtained at baseline, during therapy, and at 1, 4, 8, and 12 weeks postprocedure.RESULTS: Ten patients were randomized; six patients to surgery, four to the control group. No patient deaths, neurological deterioration, or seizures occurred. There were two infections from nonprotocol-related causes. Of the eight patients completing the treatment, the stimulation plus rehabilitation group improved significantly better than controls in the Upper Extremity Fugl-Meyer (P = 0.003 overall) and the hand function score of the Stroke Impact Scale (P = 0.001 overall).CONCLUSION: The technique of cortical stimulation to enhance stroke recovery is well tolerated and safe.