A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- To investigate adverse effects of the treatment
研究概览
简要总结
The study is an open label study on patients with Alzheimer's dementia using home based transcranial direct current (tDCS) stimulation. Aims of the study is to investigate applicability and effect of treatment.
详细描述
Active tDCS of 2mA is applied via surface based electrodes daily for 30 minutes over a 4 month period. Anodal electrode is placed over the left temporal lobe. Participants is followed up by home visit and phone calls.
Cognitive tests are performed prior to the treatment period, right after finishing 4 months of treatment and 4 months after treatment is terminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfil diagnostic criteria of probable Alzheimer's dementia.
- •Participants has to live with a caregiver.
- •If medicated with cholinesterase inhibitors or memantine, a stable dose the last three months before inclusion is required.
排除标准
- •Implant in head
- •Seizure history
- •Severe illness,
- •Psychosis or depression measured with a cornell score over
- •Mini mental status (MMSE) score<17.
研究组 & 干预措施
Treatment with tDCS
Home based treatment with tDCS for four months
干预措施: transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
To investigate adverse effects of the treatment
时间窗: 4 months
Investigation of tolerability of long term home based tDCS to patients with Alzheimer's by using the Adverse effect questionnaire for tDCS
To investigate effect of the treatment
时间窗: 8 months
Investigate possible change in cognitive tests (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Mini Mental Status Examination ( MMSE), Clock drawing test, Trail making test A \& B) after 4 months treatment and change 4 months after end of treatment
次要结局
未报告次要终点
研究者
Ole Kristian Grønli
MD/phd senior consultant
University Hospital of North Norway