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临床试验/NCT02479919
NCT02479919Unknown不适用

Treating Social Cognition Impairments in Patients With Schizophrenia With Repetitive Transcranial Magnetic Stimulation (Theta-Burst; TBS); a Multicentric Study

University Hospital, Caen4 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2017年4月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
61
试验地点
4
主要终点
V-LIS total score

研究概览

简要总结

The purpose of the study is to test a new treatment of social cognition deficits in patients with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation (theta-burst). The study will also identify clinical, psychomotor and cognitive variables that are the most sensitive to treatment, and estimate the most sensitive treatment target between patients.

详细描述

The language understanding of other people is based on linguistic decoding mechanisms (phonological, semantic, syntactic ...) but also more on subtle mechanisms for the recognition of emotions and intentions. Interact with another one requires understanding its language but also to infer emotions and intentions. There are patients with schizophrenia suffering from social cognition disorders that impair social interactions; These patients often have difficulty in extracting the non-verbal emotional content of language and have difficulty inferring the thoughts and intentions of others. Recently, investigators have suggested a link between such deficits and the hypofunction of the medial prefrontal cortex.

Transcranial magnetic stimulation is a noninvasive neuromodulation technique that increases or decreases the focal cortical excitability depending on stimulation parameters. This technique is now commonly used as a therapeutic tool. It has been tried with some success in patients with schizophrenia in some indications:

  • To reduce the auditory verbal hallucinations stimulating the temporal cortex
  • More rarely, to reduce the negative symptoms stimulating the dorsolateral prefrontal cortex.

So far, the medial prefrontal cortex was not considered as a possible target as the scalp to cortex distance prevent from using conventional stimulation coils. Recently new coils have been developed that permit stimulation of deeper cortical regions.

Investigators hypothesize that the use of transcranial magnetic stimulation with a theta burst intermittent protocol known to increase the cortical excitability and aiming the medial prefrontal cortex with a special antenna will improve social interaction capabilities of schizophrenic patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • with a diagnosis of schizophrenia or schizoaffective disorder (DSM-IV MINI R)
  • Having signed a written informed consent
  • 'Lecture Intentionnelle en situation' (LIS) score > 15 or negative 'Positive and Negative Syndrome Scale' (PANSS) score > 15

排除标准

  • Any change in psychotropic drugs (antidepressants, antipsychotics or mood stabilizers) during the two months preceding the inclusion
  • Pregnant or breastfeeding women
  • Subjects with a neurological condition or with epilepsy
  • Subjects with a counter-indication to MRI or Transcranial stimulation (electronic or metal implants)
  • Subjects that refuse to wear earplugs during MRI

结局指标

主要结局

V-LIS total score

时间窗: change from baseline in V-LIS total score compared to 30 days after the end of the treatment

次要结局

  • Motor activity measured with an actimeter(change in baseline motor activity measured with an actimeter compared to 30 days after the end of the treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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