Theta-Burst-Stimulation in Recurrent Stroke Recovery
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Relative grip force
研究概览
简要总结
The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham stimulation combined with subsequent physiotherapy. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.
详细描述
To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.
By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.
The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written consent
- •age: 40-90 years
- •recurrent stroke
- •hemiparesis with impaired hand motor function
排除标准
- •Subjects who are legally detained in an official institute (§20 MPG)
- •Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
- •Medication pump (e.g. insulin pump)
- •Metal splinters in eye or head
- •Pregnancy / breastfeeding
- •Severe Neurodegenerative disease
- •Severe Neuroinflammatory disease
- •History of seizures / epilepsy
- •Physical addiction to alcohol, medication, or drugs (excluded: nicotine)
- •Insufficient compliance
- •Present or past malignant tumor involving the central nervous system
- •Severe Psychiatric disease
- •Frequent medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
结局指标
主要结局
Relative grip force
时间窗: 3 months after enrollment
grip force as measured with vigorimeter
次要结局
- Degree of disability(After 8 days of intervention, and 3 months of enrollment)
- Stroke severity(After 8 days of intervention, and 3 months of enrollment)
- Motor cortex excitability/ Motor evoked potential(After 8 days of intervention, and 3 months of enrollment)
- Motor cortex excitability/ Resting motor threshold(After 8 days of intervention, and 3 months of enrollment)
- Activities of daily living at admission and discharge in external rehabilitation facility(After 8 days of intervention, and 3 months of enrollment)
- Relative grip force(After 8 days of intervention, and 3 months of enrollment)
- Motor cortex excitability/ Short-interval intracortical inhibition(After 8 days of intervention, and 3 months of enrollment)
- Motor cortex excitability/ Ipsilateral silent period(After 8 days of intervention, and 3 months of enrollment)
- Quality of life(After 8 days of intervention, and 3 months of enrollment)
- Days of rehabilitation after intervention phase(3 months after enrollment)
- Motor function(After 8 days of intervention, and 3 months of enrollment)
研究者
Christian Grefkes
Principal Investigator, Professor
University Hospital of Cologne