Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Interhemispheric inhibition (IHI)
研究概览
简要总结
Rationale: Acute stroke leaves many patients with functional deficits, of which upper extremity motor impairment is one of the most disabling. Evidence from imaging and electrophysiological studies converge on the idea that impaired motor function after stroke is associated with disrupted network activity in the brain. Non-invasive brain stimulation methods, like transcranial magnetic stimulation (TMS), can be used to restore disrupted network activity and have been shown to successfully facilitate recovery of motor function in patients with stroke. Application of continuous theta burst stimulation (cTBS), an inhibitory form of TMS, to the contralesional motor cortex has been shown to improve the recovery of motor function in patients with stroke. However, responsiveness to this treatment varies considerably between stroke patients and the mechanisms through which contralesional cTBS facilitates recovery of motor function remain unclear.
Objective: To determine if contralesional cTBS normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments. Age-matched healthy persons will serve as controls.
Study design: A prospective, open-label within-subject intervention study
Study population: 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity, and 40 age-matched controls.
Main endpoints: Primary endpoint: Interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex. Secondary endpoints: contralesional intracortical inhibition; effect of contralesional TMS interference on finger tapping frequency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Disabling medical conditions (severe heart disease, severe head trauma, severe mental illness);
- •Severe deficits in communication, memory or understanding which could impede participation, as determined by the treating physician;
- •Contraindications to TMS and/or MRI (ferrous implants, history of epilepsy, drug or alcohol abuse over a period of 6 months prior to the experiment, pregnancy);
- •Life expectancy shorter than one year;
- •Upper limb paresis prior to stroke onset.
结局指标
主要结局
Interhemispheric inhibition (IHI)
时间窗: Within 30 minutes after cTBS
Contralesional to ipsilesional IHI measured with a condition pulse delivered over the contralesional M1 and a test pulse delivered over the ipsilesional M1 with an interstimulus interval of 10ms. An aggregated measure (unitless) is obtained by dividing the conditioned motor-evoked potential (MEP) amplitude (in Volts) by the unconditioned MEP amplitude (in Volts). A value smaller than 1 indicates inhibition.
次要结局
- TMS interference(Within 30 minutes after cTBS)
- Intracortical inhibition (ICI)(Within 30 minutes after cTBS)
- Ipsilesional resting motor threshold (RMT)(Within 30 minutes after cTBS)
- Contralesional resting motor threshold (RMT)(Within 30 minutes after cTBS)
研究者
Jord Vink
Coordinating investigator
UMC Utrecht