Promoting Motor Recovery in Patients With Stroke by Enhancing Cerebellar-cortical Plasticity: a Randomized Double Blinded Controlled Repetitive TMS Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Berg Balance Scale (BBS) for gait and balance
研究概览
简要总结
The cerebellum is known to be strongly implicated in the functional reorganization of motor networks in stroke patients, especially for gait an balance functions. Repetitive transcranial magnetic stimulation of the cerebellum can be used to enhance these adaptive processes in stroke recovery. In this randomized, double blind, sham-controlled trial we aim to investigate the efficacy and safety of cerebellar intermittent theta burst stimulation coupled with intensive physical therapy in promoting gait recovery in hemiparetic patients due to recent stroke in the territory of the contralateral middle cerebral artery
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
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First ever-chronic ischemic stroke, i.e. at least 6 months after the stroke event,
- •Left or right subcortical or cortical lesion of the middle cerebral artery with medium-severity stroke NHISS <15 (All lesions must be documented by magnetic resonance imaging (T1- and T2-weighted images; 1.5T, GE scanners)
- •No contraindication to brain MRI
- •MEP recordable in order to evaluate the resting motor threshold (RMT)
排除标准
- •Severe general impairment or concomitant diseases (tumors, etc.)
- •Age> 80 years
- •Infections in progress
- •Patients with neurological diseases beyond stroke or with neuropsychiatric disorders or with neuropsychological disorders that could potentially compromise informed consent or compliance during the study.
- •Treatment with benzodiazepines, baclofen, antidepressants, clonidine, beta blockers and other potentially interfering drug treatments on plasticity phenomena.
研究组 & 干预措施
Cerebellar iTBS
Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
干预措施: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (Device)
Sham iTBS
Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
干预措施: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (Device)
结局指标
主要结局
Berg Balance Scale (BBS) for gait and balance
时间窗: Change from baseline at the end of three weeks treatment
Assessment of gait and balance functions
次要结局
- Barthel Index (BI)(Change from baseline at the end of three weeks treatment)
- Neurophysiological assessment of cortical activity(Change from baseline at the end of three weeks treatment)
- Gait analysis(Change from baseline at the end of three weeks treatment)
- Fugl-Meyer Assessment (FMA) scale(Change from baseline at the end of three weeks treatment)
研究者
Giacomo Koch
Head of Laboratory
I.R.C.C.S. Fondazione Santa Lucia