Evaluation of Walking After Repetitive Transcranial Magnetic Stimulation (rTMS) Inhibitory 1Hz in Vascular Hemiplegia.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Spontaneous walking speed of 10 meters. The evaluation of the primary endpoint is blind to the stimulation
研究概览
简要总结
Recovery of neurological deficits after stroke results from a reorganization of cortical activities, possibly through brain plasticity. Repetitive Transcranial Magnetic Stimulation (rTMS-MagproR30) produces changes in cortical excitability, generates phenomena of neuroplasticity. Its use to improve function after stroke, particularly of the upper limb, was validated. The investigators propose to evaluate in a prospective pilot against placebo, the benefit of rTMS at low frequency (1Hz) on the unaffected hemisphere in the short and medium term, especially on walking function and spasticity in patients with sequelae of cerebral infarction in the MCA territory with gait disturbance and motor weakness of the upper limb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
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
- •Age 18-80 years of two sexes
- •Cerebral infarction older than 12 months
- •NIH score > 4
- •Patient able to walk with or without technical assistance, Rankin score greater than or equal to 3
- •No changes can interfere with treatment of spasticity in the 3 months preceding the study (benzodiazepines, baclofen, dantrolene, botulinum toxin ...)
- •No history of generalized epilepsy unbalanced
- •Free and informed consent signed by the patient
- •MRI with ancient anatomical sequence confirming the accident sylvian
排除标准
- •Stroke with motor sequelae of cerebral infarction prior to qualifying
- •Alteration of the course prior to stroke
- •Generalized epilepsy unbalanced
- •Arrhythmias untreated
- •Injection of botulinum toxin in the previous 4 months of randomization and 2 months after randomization
- •Severe aphasia or cognitive impairment that interferes with the understanding of the tasks
- •Presence of ferromagnetic material intracranial
- •Pacemaker
结局指标
主要结局
Spontaneous walking speed of 10 meters. The evaluation of the primary endpoint is blind to the stimulation
时间窗: 3 months
Spontaneous walking speed (comfortable) to 10 meters. The gain on the walking speed of 10 meters will be appreciated by an independent evaluator, blinded to randomization. The evaluation will be made on day 1 pre (T0) and post-stimulation (T1) (for 6 hours before and after 1 h), at D8 (T2) and J21 (T3) for 2 sessions (sham and active) .
次要结局
- Distance covered in 6 min(3 months)
- - Study of the march by AQM (Gait Deviation Index)(3 months)
- - Consequence of lower limb spasticity (Modified Ashworth Scale of the quadriceps and triceps surae)(3 months)
- Analytical and functional recovery of the lower limb (Fugl-Meyer Scale, the FIM score)(3 months)
- Analytical and functional recovery of upper limb (Fugl-Meyer score and French arm test)(3 months)
- Patient satisfaction and quality of life on a visual analog scale and the SF 36.(3 months)