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临床试验/NCT04086160
NCT04086160招募中不适用

Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset

Dr WANG Shumei1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年8月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)

研究概览

简要总结

The purposes of this research are to investigate (1) if schizophrenia patients and at-risk individuals present bradykinesia and dyskinesia and (2) if tDCS improves motor performance in schizophrenia patients and at-risk individuals. The first hypothesis is that both schizophrenia patients and at-risk individuals show bradykinesia and dyskinesia, and the motor symptoms are more severe in the former than the latter. The second hypothesis is that tDCS improves motor performance in schizophrenia patients and at-risk cases.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for schizophrenia patients:
  • •a diagnosis of schizophrenia without other psychiatric diseases
  • •having stable psychotic symptoms
  • •a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
  • •having no neurological diseases and no medical conditions that affect motor performance

排除标准

  • •Inclusion Criteria for at-risk individuals:
  • •a score of nine or above in the Chinese version of the 16-item Prodromal Questionnaire (CPQ-16)
  • •a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
  • •having no diagnosis of psychiatric diseases
  • •having no neurological diseases and no medical conditions that affect motor performance
  • •No Exclusion Criteria.
  • •Inclusion Criteria for healthy controls:
  • •a score less than nine in CPQ-16
  • •a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
  • •having no diagnosis of psychiatric diseases
  • •having no neurological diseases and no medical conditions that affect motor performance.
  • •No Exclusion Criteria.

研究组 & 干预措施

healthy controls for at risk- tDCS

Experimental

干预措施: Transcranial direct current stimulation device (Soterix Medical, New York, NY) (Device)

healthy controls for at risk- sham

Sham Comparator

干预措施: Transcranial direct current stimulation device (Soterix Medical, New York, NY) (Device)

at risk- tDCS

Experimental

干预措施: Transcranial direct current stimulation device (Soterix Medical, New York, NY) (Device)

schizophrenia- tDCS

Experimental

干预措施: Transcranial direct current stimulation device (Soterix Medical, New York, NY) (Device)

schizophrenia- sham

Sham Comparator

干预措施: Transcranial direct current stimulation device (Soterix Medical, New York, NY) (Device)

at risk- sham

Sham Comparator

干预措施: Transcranial direct current stimulation device (Soterix Medical, New York, NY) (Device)

healthy controls for schizophrenia- tDCS

Experimental

干预措施: Transcranial direct current stimulation device (Soterix Medical, New York, NY) (Device)

healthy controls for schizophrenia- sham

Sham Comparator

干预措施: Transcranial direct current stimulation device (Soterix Medical, New York, NY) (Device)

结局指标

主要结局

Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)

时间窗: Within one week right after the 8th (last) session of tDCS

normalized movement time (representing severity of parkinsonism). Unit: second/mm

Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)

时间窗: Within one week right before the 1st session of tDCS

normalized movement time (representing severity of parkinsonism). Unit: second/mm

次要结局

未报告次要终点

研究者

发起方
Dr WANG Shumei
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr WANG Shumei

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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