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临床试验/NCT03338673
NCT03338673已完成不适用

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

University of Michigan1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Participant-rated Acceptability of Combination Therapy

研究概览

简要总结

People with serious mental illness often report 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 acceptable to participants, and whether it is helpful in improving a specific type of memory skill in people who have mental health conditions and memory deficits.

This study is designed so that all participants will get both treatments: the non-invasive brain stimulation and computerized cognitive exercises. Half of the participants will start with both the brain stimulation and the cognitive exercises (dual therapy), and half will start with just the computerized exercises (monotherapy). After three weeks, participants will switch to the other condition: the people who did both treatments first will switch to just the cognitive exercises alone, and the people who started with the cognitive exercises alone will then switch to doing both the brain stimulation and cognitive exercises.

Overall, participants will be in the study for about 7-8 weeks. The brain stimulation treatment involves 10 visits to the clinic over 3 weeks. The computerized cognitive exercises can be done at home, and involve 10 hours of exercises over 3 weeks. Participants will also complete paper-and-pencil assessments at the beginning, middle, and end of treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia
  • •Objective cognitive impairment in working memory
  • •Willingness to complete computerized cognitive training and undergo brain stimulation procedures

排除标准

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

研究组 & 干预措施

Dual Therapy First

Experimental

Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone

干预措施: tDCS (Device)

Dual Therapy First

Experimental

Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone

干预措施: BrainHQ (Other)

Mono Therapy First

Experimental

Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises

干预措施: tDCS (Device)

Mono Therapy First

Experimental

Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises

干预措施: BrainHQ (Other)

结局指标

主要结局

Participant-rated Acceptability of Combination Therapy

时间窗: 8 weeks

Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction)

Participant Retention in Combination Treatment

时间窗: 4 weeks

Number of participants completing every session of the combined phase of treatment

次要结局

未报告次要终点

研究者

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

Cynthia Burton

Clinical Lecturer, Department of Psychiatry

University of Michigan

研究点 (1)

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