Multicenter Study on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Post-stroke Motor Recovery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Changes from Baseline Fugl Meyer Assessment Scale (FMA)
研究概览
简要总结
Several previous studies have used tDCS as a neuromodulation tool, showing improvements in several diseases (Lefaucheur et al., 2017). Based on these observations, it is believed that the use of tDCS in combination with specific motor training may provide the opportunity to induce behavioral improvements in patients with motor deficits. As shown in previous reports brain stimulation can, in fact, interact with the intrinsic ability of the brain to "repair" damaged brain functions, increasing the involvement of compensatory functional networks and thus inducing neuroplasticity. If these low-cost, easy-to-use stimulation techniques prove to be useful in improving motor deficits with long-term effects, the current study would open up new and interesting avenues in the field of neurorehabilitation. Given the potential long-lasting effects of tDCS, there is currently a growing interest in the clinical sector with the aim to reduce motor deficits in patients with brain injury. The most widely used protocols in stroke patients include the application of either anodal on the hypsilesional hemisphere or cathodal tDCS on the unaffected hemisphere (contralateral), so as to increase and decrease the excitability of the motor cortex, respectively (Nitsche and Paulus, 2001).
The main objective of this study is to evaluate the effectiveness of transcranial direct current stimulation in enhancing the functional recovery of the upper limb of stroke patients after three weeks of neuromotor training and subsequent follow-up. The secondary objective is to evaluate the treatment effects on balance, gait, motor dexterity and disability, besides the functional recovery of the lower limb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both participants and experimenters will be prevented from having knowledge of the assigned stimulation protocol. To do so, the investigator will create a series of numbers paired with real and sham interventions while the outcome assessor will be aware of the patient-number association only.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever ischemic stroke
- •Red or white stroke
- •Barthel Index > 90 before lesion onset
排除标准
- •Previous inborn neurological disease
- •Previous acquired neurological disease
- •Previous or current major psychiatric illness
- •Epilepsy or anticonvulsant treatment
- •Use of calcium channel blocker drugs
- •Treatments with other technologies (robotics, FES, etc.)
- •Neurolytic treatments with botulinum toxin
结局指标
主要结局
Changes from Baseline Fugl Meyer Assessment Scale (FMA)
时间窗: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
Performance-based assessment of sensorimotor impairment
次要结局
- Changes from Baseline Box & Block Test (B&B)(End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up)
- Changes from Baseline Barthel Index (BI)(End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up)
- Changes from Baseline Trunk Control Test (TCT)(End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up)
- Changes from Baseline Berg Balance Scale ( BBS)(End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up)
- Changes from Baseline Functional Ambulatory Classification (FAC)(End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up)
- Changes from Baseline 10 Meters Walking Test(End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up)
研究者
Carlo Miniussi
Professor, PhD
IRCCS Centro San Giovanni di Dio Fatebenefratelli