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临床试验/NCT02460965
NCT02460965Unknown不适用

Understanding Hallucinations (Part II) - fMRI and EEG

Iris Sommer1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
Iris Sommer
入组人数
240
试验地点
1
主要终点
Difference in fMRI resting state correlates between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes.

研究概览

简要总结

Rationale: Hallucinations occur in many patients with different kinds of diseases, including psychiatric, neurological and perceptual impairment. The origin of these hallucinations is only partly understood. This prevents correct prediction of treatment response and hampers the development of new, more effective treatment strategies.

Different subtypes of hallucinations resulting from different neuropathology may exist across diagnostic entities, and be responsive to different treatment strategies. Understanding the origin of these subtypes with use of fMRI and EEG can help to make rational treatment decisions on an individual basis and enhance the development of innovative treatment paradigms.

Objective: The primary objective is to find specific abnormalities on resting state fMRI related to the pathophysiology of different subtypes of hallucinations. Secondary objectives are to find EEG connectivity measures that are related to the pathophysiology of different subtypes of hallucinations, reveal correlating patterns of EEG and fMRI that underlie the experience of hallucinations across different disorders, and to examine the frequency of spontaneous synchronized burst activations in auditory and visual cortices using fMRI.

Study design: The investigators intend to examine neural correlates of hallucinations over different disorders using resting state EEG, fMRI and sMRI in an observational study.

Study population: A total of 140 hallucinating patients will be included, 20 of each of the 7 different diagnostic groups. As a control group, 140 non-hallucinating patients with the same disorder of similar severity will be included.

Main study parameters/endpoints: The main study endpoint is the difference in resting state correlates as measured with fMRI between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes, namely: connectivity within the DMN and connectivity of the DMN to sensory cortices and the hippocampal-amygdala complex.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in the study will entail an MRI scan of 40 minutes and an EEG measurement of 5 minutes. Total visit time, including preparations, will be approximately 2,5 hours. The risks associated with participation and the benefits to the individuals are negligible. The potential benefit to society in the future is considerable if the findings lead to optimization of treatment strategies and treatment response.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

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

入选标准

  • Previous participation in the phenomenology/cognition study 13-
  • Belong to one of the diagnostic groups as described above in 4.
  • Written informed consent

排除标准

  • < 18 years of age
  • Any contraindication for a 3Tesla MRI scan

结局指标

主要结局

Difference in fMRI resting state correlates between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes.

时间窗: Three years

The main study endpoint is the difference in resting state correlates as measured with fMRI between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes, namely: connectivity within the DMN and connectivity of the DMN to sensory cortices and the hippocampal-amygdala complex.

次要结局

  • The difference in EEG correlates between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes.(Three years)
  • The auditory and visual cortex responsiveness patterns between hallucinating individuals of different subtypes.(Three years)

研究者

发起方
Iris Sommer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Iris Sommer

Prof.Dr.

UMC Utrecht

研究点 (1)

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Understanding Hallucinations (Part II) | 临床试验