Treatment of Aphasic Stroke Patients With rTMS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Hemispheric stroke scale (HSS)
研究概览
简要总结
To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic stimulation (rTMS) on post-stroke non fluent aphasia.
详细描述
Thirty patients with subacute post-stroke non-fluent aphasia were randomly allocated with a ratio 2:1 to receive real (n = 20) or sham (n = 10) rTMS of the affected motor cortex. Each patient received 1000 rTMS pulses (1 Hertz at 110% of resting motor threshold) over the unaffected Broca's area and 1000 pulses (20 Hertz at 100% resting motor threshold) over affected left Broca's area for 10 consecutive days. LANGUAGE section of hemispheric stroke scale, Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H) and NIH stroke scale were assessed before, post sessions, 1 and 2 months after the last session . Motor threshold was assessed before and after the end of last session.
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, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •acute hemiplegia with non-fluent aphasia, single thromboembolic non-haemorrhagic infarction documented by computerized tomography (CT) in the distribution of middle cerebral artery.
排除标准
- •head injury or neurological disease other than stroke,
- •Unstable cardiac dysrhythmia,
- •Infection,
- •Hyperglycaemia
- •Prior administration of tranquilizer
- •Patients with no motor evoked response recorded from first dorsal interosseus (FDI) muscle of the affected hand
研究组 & 干预措施
Real rTMS
19 subacute stroke pts with aphasia received 10 rTMS (5sessions/week) for 2 successive weeks
干预措施: repetitive transcranial magnetic stimulation (Procedure)
Sham rTMS
10 patients received sham rTMS stimulation (5 sessions/week) for 2 successive weeks
干预措施: repetitive transcranial magnetic stimulation (Procedure)
结局指标
主要结局
Hemispheric stroke scale (HSS)
时间窗: Change from Baseline in HSS at 2 months
Language assessment using hemispheric stroke scale (HSS)
次要结局
- NIH Stroke Scale (NIHSS)(Change from Baseline in NIHSS at 2 months)