Restoration of Cognitive Function With TDCS and Training in Serious Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Working Memory Capacity Composite Score
研究概览
简要总结
Development of interventions that can effectively target and remediate the cognitive and functional impairment associated with serious mental illness is a treatment priority. Transcranial direct current stimulation (tDCS) is a safe, non-invasive neuromodulation technique that is capable of stimulating brain activity to facilitate learning. The primary objective of this study is to evaluate the pairing of two therapeutic techniques, cognitive remediation and tDCS, as a cognitively enhancing intervention. This study is designed to test the hypotheses that cognitive remediation paired with tDCS will be more efficacious than cognitive remediation delivered with sham stimulation and that intervention-induced cognitive change will be sustainable.
To examine the incremental benefit of pairing tDCS with cognitive remediation, clinically stable outpatients between the ages of 18-65 who have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder will be enrolled in a double-blind, double-baseline, sham-controlled clinical trial. Participants will be randomized in a 1:1 ratio to receive either tDCS or sham stimulation concurrent with working memory focused cognitive remediation. Training will be offered to participants in a small group format. Training will consist of 48 sessions, with 2-3 sessions scheduled in a week. Each training session will last 2 hours. One hour will be spent completing cognitive exercises that require working memory skills on a computer. TDCS or sham stimulation will be offered concurrent with the first 20 minutes of training with a StarStim neuromodulator. One mA of anodal stimulation will be applied to the left dorsal lateral prefrontal cortex and the cathodal electrode will be placed in the contralateral supraorbital position. Upon completion of working memory training, participants will transition to a 45-minute bridging group focus on application of cognitive skills in everyday life. To assess intervention-induced change, working memory, other aspects of cognition, functional capacity, community functioning, and symptom severity will be assessed pre- and post-intervention. Sustainability of intervention-induced change will be assessed with an assessment session 6 weeks post-intervention. Mixed effect, repeated measure ANOVAS will be used to analyze intervention-induced change.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, interventionists, and the outcome assessors will be blind to participant condition. The neuromodulation device can be pre-programmed to deliver either tDCS or sham stimulation when an ID code is entered. The study personnel randomizing participants and programming the equipment will not have contact with participants.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible for the study if they have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder and are clinically stable at the time of enrollment
- •defined as not severely depressed or acutely manic and no hospitalizations or antipsychotic medication changes in the four weeks prior to enrollment
排除标准
- •Met criteria for a severe alcohol or substance use disorder in the last 6 months
- •Met criteria for a mild alcohol or substance use disorder in the last month
- •A history of head injury or neurological disease that has compromised cognitive functioning
- •Ability to speak English is not sufficient to understand study procedures
- •Diagnosis of learning disability, mental retardation, or pervasive developmental disorder
- •Diagnosis of a medical condition that is incompatible with tDCS procedures
- •Participant does not demonstrate understanding of study procedures during the consent process
- •A documented history of behavioral problems that prevent participation in a group intervention
- •Participated in a study of tDCS or cognitive remediation in the previous 12 months
研究组 & 干预措施
TDCS
TDCS offered concurrent with working memory focused cognitive training
干预措施: TDCS (Device)
TDCS
TDCS offered concurrent with working memory focused cognitive training
干预措施: Cognitive Remediation (Behavioral)
TDCS
TDCS offered concurrent with working memory focused cognitive training
干预措施: Bridging Group (Behavioral)
Sham
Sham stimulation offered concurrent with working memory focused cognitive training
干预措施: Sham Stimulation (Device)
Sham
Sham stimulation offered concurrent with working memory focused cognitive training
干预措施: Cognitive Remediation (Behavioral)
Sham
Sham stimulation offered concurrent with working memory focused cognitive training
干预措施: Bridging Group (Behavioral)
结局指标
主要结局
Working Memory Capacity Composite Score
时间窗: Total score at Baseline, 4 months, and 5.5 months
This is a measure of one core component of working memory. Proportion correct average from Change Detection and Change Localization Tasks. Score ranges from 0.00 to 1.00, with a higher score indicating better performance
Interference Control Composite Score
时间窗: Z-score at Baseline, 4 months, and 5.5 months
This is a measure of one core component of working memory. Performance on Rotation and Reading Complex Span Tasks was measured with z-scores. Scores range from -3 to 3, with a higher positive score indicating better performance. A score of 0 represents the sample mean at the baseline assessment. The z-scores reflecting overall performance on Rotation and Reading Span Tasks were averaged to create one z-score that reflects performance on the interference control component of working memory.
The University of California San Diego Performance-Based Skills Assessment Total Score
时间窗: Total score at Baseline, 4 months, and 5.5 months
This is a performance-based measure of functional capacity to perform activities of daily living. This measure has two scales, measuring financial and communication skills. The two scales are summed to create a total score. The Total score ranges from 0-100, with a higher score indicating better performance.
Goal Maintenance Composite Score
时间窗: D Prime at Baseline, 4 months, and 5.5 months
This is a measure of one core component of working memory. Performance on the Dot Pattern Expectancy Task and AX-Continuous Performance Task was measured with d prime. D Prime is a measure of response accuracy that takes into account both hit rate and false alarm rate. This measure of response accuracy ranges from -4.546 to 4.546, with a higher score indicating better performance. A score of 0 indicates chance level performance. D prime scores reflecting overall performance on the Dot Pattern Expectancy Task and the AX-Continuous Performance Task were averaged. The resulting d prime score reflects performance on the goal maintenance component of working memory.
次要结局
- First-Episode Social Functioning Scale Actual Performance Total Score(Total score at Baseline, 4 months, and 5.5 months)
- Novel N-Back Task D Prime Score(D prime at Baseline, 4 months, and 5.5 months)
- Brief Psychiatric Rating Scale Total Score(Total score at Baseline, 4 months, and 5.5 months)
- Complex Span Task Z-score(Z-score at Baseline, 4 months, and 5.5 months)
- Brief Negative Symptom Severity Scale Total Score(Total score at Baseline, 4 months, and 5.5 months)
- MATRICS Consensus Cognitive Battery Processing Speed Subscale and the Reasoning and Problem-Solving Subscale T-score Average(T-score at Baseline, 4 months, and 5.5 months)