Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change from baseline in Upper Extremity Fugl Meyer Assessment
研究概览
简要总结
Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke patients, but it's still unclear how tDCS should be repeated over multiple days to optimally enhance recovery and training effects. Using a late LTP-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation.
Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke.
Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper limb motor function during the subacute phase after stroke.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subacute stroke (within 1-4 weeks post stroke)
- •Acute hemiparesis (Fugl-Meyer Stage < IV) with single thromboembolic non-hemorrhagic infarction documented by a neurologist
- •Aged 18-79
排除标准
- •Absence of voluntary movement (Fugl-Meyer Stage < III)
- •Head injury or the presence of intracranial metal or intracranial lesions
- •History of cranial irradiation
- •History of epilepsy
- •Presence of a pacemaker
- •Taking anticonvulsant or neuroleptic medication
- •Substance abuse
- •Inability to understand instructions
研究组 & 干预措施
Sham
Motor training of the affected upper extremity combined with sham tDCS.
干预措施: tDCS (Device)
tDCS
Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
干预措施: tDCS (Device)
结局指标
主要结局
Change from baseline in Upper Extremity Fugl Meyer Assessment
时间窗: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
次要结局
- ARAT(Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks)
- Hand grip strength(Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks)
- 10-meter walk test(Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks)
- EuroQol-5D(12 weeks)
- Barthel Index(Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks)
- HADS(Baseline; 4 weeks and 12 weeks)
- MoCA(Baseline; 4 weeks and 12 weeks)
- Wong-Baker FACES Pain Rating Scale(Every stimulation session)
研究者
Rick van der Vliet
MSc
Erasmus Medical Center