Transcranial Alternating Stimulation in Rehabilitation: a Randomized Controlled Trial in Chronic Stroke Patients With Visuospatial Neglect
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Star Cancellation Task
研究概览
简要总结
Background Stroke is a leading cause of neurological impairments in language, motor and cognitive functions. Next to traditional stroke treatment, Non-Invasive Brain Stimulation (NIBS) offers the potential to facilitate stroke recovery as a complementary approach. Here, we aim at exploiting the principles of NIBS, specifically transcranial Alternating Current Stimulation (tACS), to promote functional recovery of people with neglect symptoms following stroke.
Objective To determine whether neglect training complemented with tACS treatment in chronic stroke patients suffering from neglect improves neglect-related symptoms compared to neglect training with sham stimulation.
Study design Double-blind randomized placebo-controlled intervention study. After enrollment and completion of baseline measurements, participants are randomly assigned to either the active tACS group or sham (control) group.
Intervention We will combine an evidence based visual scanning training (VST) with 40 minutes of (active or sham) tACS at alpha frequency. The intervention is administered three times a week for a duration of six weeks.
Outcomes of the study Performance on standard, conventional neuropsychological tests, as well as on ADL observation scales.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neurologically objectified stroke;
- •stroke occurred when patient was 18-80 years of age;
- •chronic stroke (>6 months post-stroke onset);
- •sufficient comprehension and communication skills to benefit from training (based on clinical judgement); and
- •a screening containing four neuropsychological tests will be performed to evaluate the current severity of the neglect, since the diagnosis of neglect may have been established months or even years ago in our sample of chronic stroke patients.
排除标准
- •currently engaging in cognitive rehabilitation treatment or neglect treatment;
- •physically or mentally unable to participate (based on clinical judgment);
- •hemianopsia (based on clinical judgement);
- •severe communicative disability, as task descriptions need to be understood;
- •local scalp injuries*;
- •eczema on scalp or psoriasis*;
- •diagnosed (neuro)psychiatric or neurodegenerative diseases*;
- •current alcohol and/or drug abuse*; and
- •pregnancy*.
- •due to tACS safety considerations.
结局指标
主要结局
Star Cancellation Task
时间窗: Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.
Quality of search score
次要结局
- Computerized Visual Detection Task(Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.)
- McIntosh Line Bisection Task-digitized(Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.)
- Schenkenberg Line Bisection Task(Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.)
- Baking Tray Task(Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.)
- Catherine Bergego Scale(Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.)
- Subjective Neglect Questionnaire(Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.)