Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's: a Randomized, Sham-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Apathy Symptoms
研究概览
简要总结
This is a phase 2 double-blind, randomized, sham-controlled study to investigate the effects of repeated transcranial direct current stimulation for the treatment of apathy in moderate Alzheimer's Disease in patients selected from an outpatient clinics in São Paulo, Brazil.
详细描述
Forty patients were randomized to receive either active or sham-tDCS over the left dorsolateral prefrontal cortex (DLPFC). Patients received six sessions of intervention during two weeks and were evaluated at baseline, at week one and two, and after one week without intervention. Clinical raters, patients, and caregivers were blinded. The primary outcome was apathy. Global cognition and neuropsychiatric symptoms were examined as secondary outcomes.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dementia defined by DSM-IV (Diagnostic and Statistical Manual version IV)
- •Possible Alzheimer's Disease defined by NINCDS-ADRDA (National Institute for Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association)
- •Mini Mental State Examination scores from 10 to 20
- •Apathy defined by a score equal or higher to 14 in Apathy Scale
排除标准
- •Clinical instability
- •Metallic clip in the head
- •Use of alcohol and psychotropic drugs
研究组 & 干预措施
Sham tDCS
sham-tDCS application every 2 days for 2 weeks (total of 6 applications)
干预措施: Transcranial direct current stimulation (Device)
Transcranial direct current stimulation
tDCS application every 2 days for 2 weeks (total of 6 applications)
干预措施: Transcranial direct current stimulation (Device)
结局指标
主要结局
Apathy Symptoms
时间窗: Differences in outcome measure comparing second week to baseline
Apathy evaluated by Apathy Scale by Starsktein et al, 1992, which consists of 14 items phrased as questions that are to be answered by the caregiver on a four-point Likert scale. The total score range from 0 to 42, with higher scores indicating greater apathy severity. Apathy was assessed at baseline and at the end of the sixth session (second week).
次要结局
未报告次要终点
研究者
Claudia Kimie Suemoto
Assistant Professor
University of Sao Paulo