Therapeutischer Einsatz Der Schwachen Gleichstromstimulation (tDCS) Bei Motorisch-kognitiven Defiziten Nach Schlaganfall
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 4
- 主要终点
- KAS (Cologne Apraxia Screening)
研究概览
简要总结
The objective of the clinical trial is to investigate whether weak transcranial direct current stimulation (tDCS) can ameliorate the motor cognitive deficit apraxia during stroke rehabilitation. Stroke patients with apraxia will either receive a real stimulation or a sham stimulation (placebo) for 10 minutes at a time on 5 consecutive days during their in-patient stay in a rehabilitation center. Additionally, motor tasks are performed before and after the stimulation. The effect of the weak current stimulation on motor function is assessed 3-4 days after the last stimulation and 3 months after enrollment.
详细描述
Despite the high incidence of the motor cognitive deficit apraxia after left-hemispheric stroke, evidence-based therapies do not exist. This randomized controlled clinical trial (RCT) investigates whether anodal transcranial direct current stimulation (tDCS) as an add-on therapy during neuro-rehabilitation can ameliorate apraxic deficits in patients with left hemisphere stroke. Therefore, anodal tDCS is applied over the parietal cortex of the left, lesioned hemisphere with an intensity of 2 mA for 10 minutes at a time on 5 consecutive days in combination with motor tasks before and after the stimulation. The effect of the stimulation is compared to a sham stimulation. Moreover, application of a pre-programmed study mode ensures a double-blind study design (patient and investigator). The performance in the apraxia test KAS (Cologne Apraxia Screening) 3-4 days after the last stimulation, compared to baseline, serves as primary endpoint of the study. Secondary endpoints are evaluated using various apraxia tests, motor tests and neuropsychological tests 3-4 days after the last stimulation and 3 months after enrollment.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •left hemispheric ischemic stroke in the subacute/ chronic phase (>10 days and <180 days post-stroke)
- •clinical confirmation of apraxia by KAS (Cologne Apraxia Screening), Cut-off ≤ 76/ 80 points;
- •age 18 - 90 years;
- •written Informed Consent
排除标准
- •pregnancy, breastfeeding and women without exclusion of pregnancy
- •patients with clinical manifestation of a stroke prior to the index-stroke
- •malignant disease with affection of central nervous system
- •life expectancy <12 months
- •current addiction to alcohol or drugs or other addictive disease (exception: nicotine)
- •current clinically manifest psychiatric disorders, such as schizophrenia or severe depressive episode
- •epileptic seizure within the past two years
- •continuous medication during the intervention phase with benzodiazepine, antipsychotics of high potential and anti-epileptic drugs taken for prophylaxis of epileptic seizures
- •enrollment in other studies with brain stimulation in the time period after the index stroke
- •heart pacemaker
- •electrodes for deep brain stimulation or other metal implants in the head (expected are dental fillings and inlays)
- •craniectomy or trepanation
- •vulnerable skin lesions at electrode positions
- •poor motivation/ cooperation
结局指标
主要结局
KAS (Cologne Apraxia Screening)
时间窗: 3-4 days after stimulation
Degree of apraxia
次要结局
- Goldenberg Imitation(3-4 days after stimulation, and 3 months after enrollment)
- de Renzi Imitation(3-4 days after stimulation, and 3 months after enrollment)
- Jebsen Taylor Hand Function Test (JTHFT)(3-4 days after stimulation, and 3 months after enrollment)
- Strength of hands (MRC)(3-4 days after stimulation, and 3 months after enrollment)
- modified Ranking Scale (mRS)(3-4 days after stimulation, and 3 months after enrollment)
- KAS (Cologne Apraxia Screening)(3 months after enrollment)
- National Institute of Health Stroke Scale (NIHSS)(enrollment)
- Aphasia Check List (ACL-K)(3-4 days after stimulation, and 3 months after enrollment)
- de Renzi actual tool use(3-4 days after stimulation, and 3 months after enrollment)
- Action Research Arm Test (ARAT)(3-4 days after stimulation, and 3 months after enrollment)
- Gripforce (Vigorimeter)(3-4 days after stimulation, and 3 months after enrollment)
研究者
Gereon R. Fink
Univ.-Prof. Dr. med.
University of Cologne