Therapeutic Effect of Direct Current Stimulation on Cognitive Function of Mild to Moderate Alzheimer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Minimental state Examination
研究概览
简要总结
The current study is planed to compare the efficacy of real (anodal and cathodal) vs sham transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex (DLPFC) on cognitive functions and cortical excitability of patients with Alzheimer disease (AD).
Thirty three with mild to moderate Alzheimer's disease (AD) patients (diagnosis of probable AD according to the criteria of the National Institute of Neurological and Communicative Disorders and Stroke Alzheimer Disease and Related Disorders Association [NINCDS-ADRDA] were included in this study) were randomly classified into one of three groups (eleven for each group). The first group received anodal tDCS over left DLPFC and 2rd group received cathodal tDCS on the left DLPFC and the 3rd group received sham tDCS stimulation, daily for 10 consecutive days (5 days/week for 2 weeks). Minimental State Examination (MMSE), psychometric assessment for cognitive functions (MMSE, Wechsler memory scale, Wechsler adult Intelligent scale) were assessed before, after 10th sessions, and then after 1 and 2 month. Cortical excitability was assessed in both hemispheres before and after the end of sessions. Neurophysiological evaluations included resting and active motor threshold (rMT and aMT), and cortical silent period (CSP).
At the time of recruitment, none of the patients taking antidepressants, or neuroleptic, sedative-hypnotic drugs for at least two weeks before the assessment. All participants or their caregivers will give informed consent before participation in the test and after full explanation of the study protocol.
Outcome: The real group received (anodal and cathodal) tDCS are expected to have more improvement on cognitive functions compared to sham tDCS group. tDCS is considered new adjuvant non pharmacological therapeutic tool for management of AD patients with mild to moderate degree dementia.
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, Investigator)
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thirty patients with a diagnosis of probable AD according to the criteria of the National Institute of Neurological and Communicative Disorders Association (NINCDS-ADRDA) (McKhann G et al.,1994) will be included in this study.
排除标准
- •previous history of stroke
- •Metabolic disturbances
- •Other major medical illness or epilepsy
- •Patients metallic objects in the body
- •Patients subjected to a craniotomy in the past.
研究组 & 干预措施
Group 1
11 patients We Applied real anodal tDCS on the left dorsolateral prefrontal cortex (DLPFC)20 minutes every day for 10 consecutive days.
干预措施: Direct current stimulation using Anodal electrode (Procedure)
Group 2
11 patients we applied cathodal tDCS on left DLPFC for 20 minutes every day for 10 consecutive days.
干预措施: direct current stimulation using cathodal electrode (Procedure)
Group 3
11 patients We applied sham stimulations(anodal tDCS) on the left DLPFC for few seconds the stop stimulations 2 mA every day for 10 days.
干预措施: Sham direct current stimulation (Procedure)
结局指标
主要结局
Minimental state Examination
时间窗: base line and after 2 months
To measure the cognitive function in alzheimer patients through measuring orientation, Registration, Attention and calculation, Recall,language, and copying with a total score 30.
次要结局
- changes in cortical excitability(Base line and after 10 days)
- Wechsler memory scale(Basal and 2 months)
- Intelligent questant ( IQ)(basal and 2 months)