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Repetitive Transcranial Magnetic Stimulation for Treating Depression: A Functional Magnetic Resonance Imaging Study

2019年2月8日 更新者:Washington University School of Medicine

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder: A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study

This protocol, "Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder (MDD): A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study," is an open-label pilot treatment study. The purpose of the present protocol is to treat participants with a diagnosis of Major Depressive Disorder with 4 weeks of rTMS, performing fcMRI and EEG studies prior to and following treatment to determine if treatment response is related to changes in fcMRI and/or EEG results. The investigators hypothesize that patients who respond to treatment will display changes in functional connectivity patterns thought to be related to the occurrence of depressive symptoms.

研究概览

详细说明

Depression is accompanied by rumination that supports inwardly focused cognitive attention on negative events and emotions. There is evidence to indicate that one aspect of this ruminative behavior lies in an abnormal increase in intra-regional connectivity among elements of the default mode network (DMN). It is also widely recognized that depression is associated with disturbances of cognition that include deficits in attentional processing, including both reductions in processing speed and deficits in selective attentional processing that are considered a part of executive function. Thus, there is at least equal reason to believe that attention and executive control networks might show changes in intra-regional functional connectivity. Given the attentional deficits associated with MDD, we hypothesize that there will be a weakening of intra-network resting state BOLD functional connectivity (rs-fcMRI) in addition to the strengthened connectivity reported by others.Further, we suggest that these shifts in intra-regional connectivity extend to the well-recognized anti-correlated activity between these two networks and support the intrusion of introspective, ruminative thought on cognitive activities that require externally directed attention. To test this hypothesis, we will use fMRI resting state functional connectivity to examine shifts in network connectivity prior to and following rTMS treatment for depression.

研究类型

介入性

注册 (实际的)

4

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

    • Missouri
      • Saint Louis、Missouri、美国、63110
        • Washington University

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 50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:

SCREENING/DIAGNOSTIC REQUIREMENTS:

  • Male or female outpatients, ages 18-50 (some literature has shown increasing cortical distance with age that may affect treatment outcome
  • Hamilton Rating Scale of Depression (HRSD-24) > 18
  • New onset major depression or untreated recurrent major depression per DSM-IV-TR38 criteria.
  • Not taking antidepressant medication or any other psychotropic medication
  • Using an adequate contraceptive method
  • Able to give informed consent
  • Available for 4 weeks of daily therapy, working hours, Mon.-Fri.
  • English-speaking

Exclusion Criteria:

DIAGNOSTIC EXCLUSIONS:

  • Co-morbid psychiatric diagnosis of bipolar disorder, acute OCD, schizophrenia or schizoaffective or concurrent treatment with outpatient ECT, or personality disorder or MDD with suicidal ideation as determined by history and/or by P.I. examination requiring hospital admission or referral for acute care.
  • Previous failure to respond to treatment with rTMS
  • Failure to achieve satisfactory improvement in depression after two or more adequate trials of antidepressant medications.

MEDICAL EXCLUSIONS:

  • Patients newly diagnosed with thyroid dysfunction
  • History of drug and/or ETOH dependence
  • History of seizures
  • History of head injury with loss of consciousness > 5 minutes
  • Any implantable metal object in the skull or near their head
  • Any implantable devices such as a cardiac pacemaker, vagal nerve stimulator, etc.
  • Positive urine pregnancy test
  • Severe migraine headaches uncontrolled with routine non-narcotic medication
  • Any medical condition in the opinion of the Investigator that might confound the results of the study Contraindications to fcMRI procedure
  • Intake of NSAIDS, narcotic or muscle relaxants within 72 hours of the fMRI protocol.
  • Claustrophobia.
  • Left-handedness (may influence cerebral cortical hemispheric dominance).
  • Inability to tolerate, or medical contraindication to MRI testing (e.g. metal prostheses or implants, history of claustrophobia)

PROTOCOL SPECIFIC EXCLUSIONS:

  • Unable to determine motor threshold for determining treatment dose with rTMS device
  • Mini Mental Status Exam (MMSE)70 score < 24.

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:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Transcranial Magnetic Stimulation
Open-label transcranial magnetic stimulation
Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.
其他名称:
  • Magstim Rapid stimulator

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
Hamilton Depression Rating Scale-24 Point Version (HDRS-24)
大体时间:At study entry and within 2 days of exiting 4 weeks of rTMS treatment
HDRS-24 will be used to measure response to rTMS treatment. A 50% decrease in HDRS-24 score will indicate treatment response; HDRS-24 < 10 will indicate remission.
At study entry and within 2 days of exiting 4 weeks of rTMS treatment

次要结果测量

结果测量
措施说明
大体时间
fCMRI Results
大体时间:At study entry and within 2 days of exiting 4 weeks of rTMS treatment
Imaging studies will be compared to determine if any changes in functional connectivity can be correlated with treatment response.
At study entry and within 2 days of exiting 4 weeks of rTMS treatment

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:Jose Garcia, MD、Washington University School of Medicine

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

2010年1月1日

初级完成 (实际的)

2013年9月1日

研究完成 (实际的)

2013年9月1日

研究注册日期

首次提交

2009年11月30日

首先提交符合 QC 标准的

2010年7月13日

首次发布 (估计)

2010年7月14日

研究记录更新

最后更新发布 (实际的)

2019年2月18日

上次提交的符合 QC 标准的更新

2019年2月8日

最后验证

2019年2月1日

更多信息

与本研究相关的术语

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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