Transcranial Direct Current Stimulation for Treatment of Depression in Parkinson's Disease, a Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Depression
研究概览
简要总结
Investigation of possible benefits of transcranial direct current stimulation (tDCS) as a treatment of depression in patients with Parkinson's Disease, through a randomized placebo-controlled clinical trial.
详细描述
We aim to investigate the effects of transcranial direct current stimulation (tDCS) as treatment for depression in patients with Parkinson's Disease. We have designed a clinical trial in which volunteers that fulfill inclusion criteria will receive 15 sessions of tDCS during 1 week (3 sessions a day, with 30 minutes interval in between). Subjects will be randomly allocated into two groups, one that will receive the real intervention (active) and the other that will receive the placebo intervention (sham). The collaborator in charge of administering the session will not participate in the evaluations, keeping both subjects and evaluators blinded to the nature of the sessions. Subjects will be evaluated at baseline, and after the end of sessions, 1 week, 4 weeks and 8 weeks, the latter being the main outcome.
We aim to enroll 50 subjects, 25 for each arm. The sample size calculation took into consideration previous clinical trials using tDCS for depression in different settings.
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
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease
- •Geriatric Depression Scale - 15 higher that 5
- •Major Depression Disorder
排除标准
- •CNS disease other than Parkinson's Disease (i.e. epilepsy, stroke)
- •Mental disorder other than depression on anxiety disorder (i.e. bipolar disorder, schizophrenia)
- •Previous neurosurgical intervention (i.e. DBS)
- •Current use of antidepressant drug
- •High suicidality risk
- •Limited capacity of understanding written and spoken Portuguese
结局指标
主要结局
Hamilton Rating Scale for Depression
时间窗: 8 weeks
次要结局
- Quantitative EEG(8 weeks)
- Geriatric Depression Scale -15(8 weeks)
- Parkinson's Disease Questionnaire - 39(8 weeks)
- Mini-Mental State Examination(8 weeks)
- Hamilton Anxiety Rating Scale(8 weeks)
- Montgomery-Åsberg Depression Rating Scale(8 weeks)
- Lille apathy rating scale(8 weeks)
研究者
Pedro Caldana Gordon
Principal Investigator
Hospital Santa Marcelina