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Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic (TDCSSCHIZ)

2017年8月27日 更新者:Robert C. Smith MD PhD、Nathan Kline Institute for Psychiatric Research

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.

研究概览

地位

完全的

干预/治疗

研究类型

介入性

注册 (实际的)

33

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • Orangeburg、New York、美国、10962
        • Nathan Kline Institute for Psychiatric Research

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosis of schizophrenia spectrum disorder History of cigarette smoking

Exclusion Criteria:

  • Seizure disorder or current treated neurological illness Current Acute exacerbation of psychotic state

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Active tDCS
tDCS 2 ma for 20 minutes with anode at DLPFC once a day for 5 days
Transcranial Direct Current Stimulation
假比较器:Sham tDCS
tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days
Transcranial Direct Current Stimulation

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in Cigarette Craving
大体时间: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.
Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Cognitive Performance
大体时间:Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)
The MATRICS Consensus Cognitive Battery (MCCB) was used to measure cognitive performance. Seven Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program from raw scores on 10 individually administered subtests. We used the revised MCCB program (beta version) which allows for calculation of Domain and Composite scores with missing data. The Domain T-scores are percentile-ranked and range from <20 (<0.1 percentile) to >80 (>99.9 percentile). The Composite scores are also percentile-ranked and range from <213 (T<20, <0.1 percentile) to >487 (T>80, >99.9 percentile). Higher scores after baseline represent better outcomes. Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes.
Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)

其他结果措施

结果测量
措施说明
大体时间
Change From Baseline in Psychiatric Symptoms
大体时间:Baseline and after 5 tDCS sessions
The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Scores closer to 30 after baseline represented better outcomes. Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes.
Baseline and after 5 tDCS sessions

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Robert C Smith, MD、Nathsan Kline Institute for Psychiatric Research

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年4月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2014年4月26日

首先提交符合 QC 标准的

2014年4月29日

首次发布 (估计)

2014年5月1日

研究记录更新

最后更新发布 (实际的)

2017年8月30日

上次提交的符合 QC 标准的更新

2017年8月27日

最后验证

2017年8月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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