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临床试验/NCT05111548
NCT05111548
已完成
不适用

Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Severe Mental Illness

University of Michigan1 个研究点 分布在 1 个国家目标入组 19 人2021年9月8日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Schizophrenia
发起方
University of Michigan
入组人数
19
试验地点
1
主要终点
Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score
状态
已完成
最后更新
去年

概览

简要总结

People with serious mental illness often experience difficulties with thinking skills like memory. These difficulties can make it harder to perform day-to-day activities. The purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is helpful in improving a specific type of memory skill in people who have mental health conditions.

The study is a randomized clinical trial, meaning that participants will be randomly assigned to receive either 'active' or 'inactive' brain stimulation. All participants will complete computerized cognitive exercises, also known as cognitive training.

Overall, participants will be in the study for 6-8 weeks. The study involves 10 visits to the clinic over 2-4 weeks for cognitive training and either active or inactive brain stimulation. Participants will also complete paper-and-pencil assessments at the beginning and end of treatment, and one month after treatment ends.

注册库
clinicaltrials.gov
开始日期
2021年9月8日
结束日期
2023年5月12日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Cynthia Burton

Clinical Assistant Professor, Department of Psychiatry

University of Michigan

入排标准

入选标准

  • Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia
  • Willingness to participate in study procedures

排除标准

  • History of neurological illness or injury (e.g., stroke)
  • History of loss of consciousness
  • Diagnosed intellectual disability
  • Current substance use disorder
  • Current mania or moderate depression or severe psychosis
  • Current serious suicidal ideation/behavior
  • Pregnant or trying to become pregnant, or currently lactating

结局指标

主要结局

Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score

时间窗: Baseline to post-treatment (up to 4 weeks)

MCCB spatial span total raw score. Spatial span is a subtest of the standardized MCCB and a measure of visual working memory. Examinees must tap sequences of blocks in the same order as the examiner then in reverse. Correct responses are summed for the forward and backward condition to create a total raw score (0-32, where higher scores indicate better performance).For change scores, a positive value indicates improvement (i.e., higher total score).

Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score

时间窗: Baseline to post-treatment (up to 4 weeks)

MCCB letter-number span total raw score. Letter-number span is a subtest of the standardized MCCB and a measure of verbal working memory. Examinees must reorder sequences of numbers and letters spoken out loud by the examiner. Correct responses are counted to create a total score (0-24, where higher scores indicate better performance). For change scores, a positive value indicates improvement (i.e., higher total score).

次要结局

  • Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A(Baseline to post-treatment (up to 4 weeks))
  • Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B(Baseline to post-treatment (up to 4 weeks))

研究点 (1)

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