Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Motor Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Change in upper extremity Fugl-Meyer score, after intervention
研究概览
简要总结
Neurological deficits and motor disorders are extremely common after stroke. Physical therapies can improve the autonomy of these patients, but despite an intensive stationary neurorehabilitation, severe deficits often persist. Complementary therapies that could improve recovery would therefore be very welcome.
Transcranial direct current stimulation (tDCS) induces, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of certain cerebral regions. An increasing number of studies show that this modulation of brain activity can improve motor functions in patients with brain lesions and increase the effect of physical therapies. However, the "optimum" configuration of tDCS and the induced effects remain to be characterized and investigated.
The investigators therefore propose to carry out a study including a pilot phase in order to determine the most efficient tDCS setup. The optimum setup of of the pilot phase will be compared to a placebo condition in a multicentric main study.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke
- •≤ 4 weeks after stroke onset
- •Paresis of upper limb with Fugl-Meyer score between 15 and 55 at study entry
- •Capable of participating during treatment sessions of 30-60 minutes
- •Informed consent obtained
排除标准
- •Incapacity to understand study information or task instructions during trial.
- •New additional stroke during rehabilitation
- •Reduced vigilance or delirium
- •Severe language deficits
- •Preexisting affection of an upper limb
- •Severe spasticity or dystonia
- •Severe co-morbidities (e.g., traumatic, rheumatologic, neurodegenerative disease)
- •Pregnancy
- •Pacemaker
- •Skull breach
- •History of seizures or epilepsy
- •Metallic object in the brain
- •Other contraindication to non-invasive brain stimulation
结局指标
主要结局
Change in upper extremity Fugl-Meyer score, after intervention
时间窗: Difference between the week before the intervention and the week after intervention
Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
次要结局
- Change in EEG functional connectivity, after intervention(Difference between the week before the intervention and the week after intervention)
- Change in amplitude of motor evoked potentials, after intervention(Difference between the week before the intervention and the week after intervention)
研究者
Adrian Guggisberg
Médecin adjoint agrégé, assistant professor
University Hospital, Geneva