Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change From Baseline in Cigarette Craving
研究概览
简要总结
This is a study of the effects of tDCS on smoking, craving for cigarettes, cognition, and psychiatric symptoms in schizophrenic patients who are current smokers or have a history of regular cigarette smoking. It assesses smoking with CO monitoring, nicotine and nicotine levels, and craving with QSU scale and response to craving slides. Cognition is measured by MCCB, symptoms are measured by PANSS and hallucination scale.
This is a double-blind sham-controlled study with active tDCS 2ma or 20 minutes over 5 days, and sham tDCS for 40 seconds on each sham occasion.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia spectrum disorder History of cigarette smoking
排除标准
- •Seizure disorder or current treated neurological illness Current Acute exacerbation of psychotic state
研究组 & 干预措施
Active tDCS
tDCS 2 ma for 20 minutes with anode at DLPFC once a day for 5 days
干预措施: tDCS (Device)
Sham tDCS
tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days
干预措施: tDCS (Device)
结局指标
主要结局
Change From Baseline in Cigarette Craving
时间窗: Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)
The Brief Questionnaire on Smoking Urges (QSU-Brief) was used to measure cigarette cravings. Scores ranged from a minimum of 1 ("Strongly Disagree") to a maximum of 7 ("Strongly Agree") and were determined by self-reported responses to 10 statements about having cravings for smoking. Scores closer to 1 after treatment would indicate a better outcome. Responses to each of the 10 items in the scale were summed for one total score. With 10 items on this scale with a range of scores from 1 to 7, on each occasion of rating the minimum score would be 7 and the maximum score would be 70.
次要结局
- Change From Baseline in Cognitive Performance(Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline))
研究者
Robert C. Smith MD PhD
Research Psychiatrist
Nathan Kline Institute for Psychiatric Research