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临床试验/NCT00217217
NCT00217217终止3 期

Low Field Magnetic Stimulation in Bipolar Depression

Mclean Hospital2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2004年9月最近更新:
适应症

试验速览

阶段
3 期
状态
终止
入组人数
13
试验地点
2
主要终点
Positive and Negative Affect Scale

研究概览

简要总结

Individuals with bipolar depression who had a particular kind of brain imaging reported improved mood after the imaging. This effect may be linked to the changing magnetic fields used during these magnetic resonance imaging studies. The current studies are designed to further explore the important parameters of this effect and to clarify the degree and duration of the mood effects.

详细描述

An initial study using proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) in bipolar depressed individuals was associated with reports of improved mood. These studies employed oscillating magnetic fields similar to those used in functional MRI (fMRI), but which differ from the usual fMRI scan in field direction, waveform frequency, and strength. As the abbreviation EP-MRSI is used to describe several relatively common MR sequences, the specific potential clinical procedure being used is referred to as low field magnetic stimulation or LFMS. Following these initial results, investigators are conducting studies to determine the critical variables in both subjects and treatment for optimal response. Studies are also underway to characterize the response of specific depression symptoms, the degree of response, and the duration of response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary diagnosis of bipolar disorder.
  • Current depression.

排除标准

  • Contraindication for MRI due to metal in eyes/head
  • Claustrophobia.
  • Inability to lie flat.
  • History of brain injury.

结局指标

主要结局

Positive and Negative Affect Scale

时间窗: pre/post-treatment

次要结局

  • Visual-Analog Scales(pre/post-treatment)
  • Montgomery Asberg Depression Rating Scale (MADRS)(pre-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Rohan

Imaging Physicist

Mclean Hospital

研究点 (2)

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