rTMS for Working Memory Deficits in Schizophrenia
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Working Memory Deficits in Schizophrenia and Effects on Brain Structure
研究概览
详细说明
This study is a randomized, double blind, sham controlled study to evaluate the efficacy of repetitive transcranial magnetic stimulation as a treatment for working memory deficits in individuals with schizophrenia or schizoaffective disorder between 18 and 59 years of age. The study duration is approximately 3 months, with the rTMS sessions lasting for 4 weeks, 5 times a week, for about 1 hour each. Several scales will be used to assess symptom severity as part of the clinical assessment. Cognition will be assessed using a validated battery and the N-back task.
This study also involves a type of brain imaging known as magnetic resonance imaging (MRI) at the beginning and at the end of the 4 weeks of daily rTMS to better understand the effects of rTMS on brain structure and function. Investigators will measure the size and connections of different parts of the brain to assess brain structure and blood flow while you are completing some basic tasks to assess brain function. We will also collect two blood samples (before and after rTMS treatment) to see if certain proteins change in response to treatment. Finally, an analysis of genetic material will be conducted to see if genes play a role in differences in how people respond to treatment.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大
- Centre for Addiction and Mental Health
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Between 18 and 59 years of age
- Current diagnosis of Schizophrenia or Schizoaffective Disorder
- Able to provide written informed consent
- Fluency in the English Language
Exclusion Criteria:
- Have a history of substance abuse or dependence in the last 6 months
- Have a concomitant major and unstable medical or neurologic illness
- Have a history of seizures or have a first degree relative with a history of a seizure disorder
- Current pregnancy or a plan to become pregnant during the duration of the study
- Clinical instability: determined by treating physician
- Have received electroconvulsive therapy (ECT) within the last year
- Have a history of repetitive transcranial magnetic stimulation (rTMS)
- Are taking a benzodiazepine at a dose greater than Lorazepam 2mg or equivalent
- Are taking any non-benzodiazepine anticonvulsant
- Have a cardiac pacemaker, cochlear implant, implanted electronic device or non-electric metallic implant
学习计划
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Active rTMS
Active treatment will be delivered at an intensity that is 90% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 25 stimulation trains of 30 stimuli each (i.e., 750 stimuli) and an intertrain interval of 30 sec. Treatment will be applied in sequential order bilaterally to the left and right dorsolateral prefrontal cortex (DLPFC). The order of bilateral stimulation (i.e. right then left or left then right) will be held constant for all 20 treatments. Intervention: Device: Repetitive Transcranial Magnetic Stimulation |
rTMS 是一种非侵入性程序，涉及使用磁场刺激神经细胞。
其他名称：
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假比较器：Sham rTMS
Sham stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but with only the side-edge resting on the scalp. The coil will be angled 45 degrees away from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects. Intervention: Device: Repetitive Transcranial Magnetic Stimulation |
rTMS 是一种非侵入性程序，涉及使用磁场刺激神经细胞。
其他名称：
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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 |
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Performance on the N-back working memory task
大体时间：4 weeks
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The primary outcome measure will be the performance on the N-back working memory task. Specifically, we will evaluate if rTMS results in a change in percent of correct responses in the N-back task. Note: the N-back is a continuous performance task that is commonly used to measure attention and working memory. |
4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Brain Imaging Changes
大体时间：4 weeks
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For brain imaging we will test for group differences using: (1) cortical thickness (2) volumetric measures, (3) diffusion based measures.
Statistical tests measuring these differences will be conducted at baseline and following the final rTMS treatment session.
We will control for possible effects of neuroleptic medication on MRI measures by regressing mean dosage levels multiplied by number of years on medication, for each of five classes of medication (typical neuroleptics, atypical neuroleptics, antiparkinsonian anticholinergics, lithium, benzodiazepines)
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4 weeks
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合作者和调查者
调查人员
- 首席研究员：Aristotle Voineskos, MD, PHD、Centre for Addiction and Mental Health
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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