The Treatment Effectiveness of Combined tDCs and Neurofeedback (NF) for Patients With Cognitive Deficits After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change score in Trail Making Test A & B from baseline
研究概览
简要总结
This is a double blinded, randomized control trial with a pretest-posttest control and interventional groups design. Both the assessor and participants are blinded to all assessments and evaluations. All patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened initially by a series of screening test. Suitable patients are assigned randomly to 3 groups respectively. Group 1 is the combined transcranial direct current stimulation (tDCS) and neurofeedback group. Group 2 is the neurofeedback group. Group 3 is the control group with sham neurofeedback training.
详细描述
Treatment sessions for all three groups are conducted by the investigators who has training in neurofeedback and transcranial direct current stimulation (tDCs). Each participant performed 10 training sessions on different days. Sessions were conducted 3-5 times a week The tDCS + neurofeedback group will carry out 30 minutes tDCS and 30 minutes neurofeedback training.
The real neurofeedback group will carry out 30 minutes neurofeedback training. The sham neurofeedback group will conduct the 30 minutes sham neurofeedback training.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging
- •Below 16 th percentile cut off in Hong Kong Montreal - Cognitive Assessment (HK - MoCA) (range from 17-25/30).
- •Less than twelve months since onset of stroke at study entry
- •Able to follow simple command
排除标准
- •Patients with severe dysphasia (either expressive or comprehensive) which restricts communication;
- •History of other neurological disease, psychiatric disorder, or alcoholism;
- •Significant impairment in visual or auditory function
- •Any additional medical or psychological condition that would affect their ability to comply with the study protocol.
结局指标
主要结局
Change score in Trail Making Test A & B from baseline
时间窗: One day before the treatment , up to 4 weeks, up to 16 weeks
Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
次要结局
- Change score in Functional Independence Measure (FIM) from baseline(One day before the treatment , up to 4 weeks, up to 16 weeks)
- Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA - SIP 30)(One day before the treatment , up to 4 weeks, up to 16 weeks)
研究者
Marko Chan
Principal Investigator
Kowloon Hospital, Hong Kong