The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- BDI score
研究概览
简要总结
Depression is common in Parkinson's disease (PD), but the effective treatment is not established yet. tDCS is a non-invasive brain stimulation to modulate brain function. The tDCS on the depression in general population were already conducted, but not in PD. This study is to know whether transcranial direct current stimulation (tDCS) is effective for the treatment of depression in PD. Participant will be asked to visit three consecutive days for the non-invasive stimulation.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •UK Parkinson's disease brain bank criteria
- •more than 19 years old
- •Able to provide consent for the protocol
- •Depression (based on DSM-IV criteria)
排除标准
- •Unpredictable symptom fluctuations
- •Contraindication to tDCS (i) irritations, cuts, lesions in the brain (ii) any preexisting unstable medical conditions, or conditions that may increase the risk of stimulation such as uncontrolled epilepsy (iii) history of severe cranial trauma with alteration of the cranial anatomy or metallic intracranial implants (iv) history of seizure
- •Subjects without the capacity to give informed consent
- •If participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as excessive fatigue, general frailty, or excessive apprehension
研究组 & 干预措施
Real tDCS
- Constant weak electric currents through scalp via two electrodes will be delivered.
- Current intensity: 2mA, 20min/day
干预措施: transcranial direct current stimulation (tDCS) (Device)
Sham tDCS
- a 1 mA current, for 30 s giving an initial sensation of tDCS while minimizing stimulatory effects
- Ramp up and ramp down was over 10 s. (Ref. Loo CK et al., Br J Psychiatry 2012;200:52-9)
干预措施: transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
BDI score
时间窗: (1) before the1st visit (within one month) (2) right after the 3rd tDCS (3) within one months after the 3rd tDCS
The changes of Beck depression inventory after tDCS
次要结局
- HDRS score((1) before the 1st visit (within one month) (2) right after 3rd tDCS, within 24 hours (3) within one months after the 3rd tDCS)
- MADRS score((1) before the 1st visit (within one month) (2) right after the 3rd tDCS, within 24 hours (3) within one months after 3rd tDCS)
- resting state functional MRI((1) before the 1st visit (within one month) (2) after the 3rd tDCS, within 24 hours (on the same day as the 3rd tDCS))