Transcranial Direct Current Stimulation Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)
研究概览
简要总结
Negative symptoms, which include the loss of motivation, social withdrawal and reduced emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. These negative symptoms lead to significant functional impairment and enduring disability in these youth. At present, there are no established treatments for negative symptoms. Recent evidence from independent studies, however, suggests two promising novel treatment approaches for negative symptoms, transcranial direct current stimulation (tDCS), and computerized remediation strategies. The primary aim of this study is to evaluate if tDCS combined with a virtual reality-based computerized remediation (VR) is effective for treating negative symptoms in CHR youth, thereby mitigating the enduring functional disability these symptoms cause.
详细描述
Negative symptoms, which include amotivation, social withdrawal and diminished emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. Negative symptoms lead to significant functional impairment and enduring disability in these youth regardless of subsequent conversion to psychosis. At present, there are no established treatments for negative symptoms. Recent evidence from independent studies, however, suggests two promising novel treatment approaches for negative symptoms, transcranial direct current stimulation (tDCS), and computerized remediation strategies, both of which have revealed significant therapeutic effects on negative symptoms in schizophrenia (SZ). tDCS involves delivery of a low intensity continuous electrical field to the frontal cortex. tDCS is very safe and well tolerated, and is currently being investigated as a treatment for several psychiatric disorders. tDCS is also Health Canada approved for the treatment of major depressive disorder. The primary aim of this randomized controlled trial is to evaluate if tDCS combined with a virtual reality-based computerized remediation (VR), administered three times per week for four weeks, is effective for treating negative symptoms in CHR youth, thereby mitigating the enduring functional disability these symptoms cause.
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
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 16 and 30;
- •meet CHR criteria for a psychosis risk syndrome determined by the Structured Interview for Prodromal Symptoms (SIPS);
- •have a Scale of Prodromal Symptoms (SOPS) negative subscale (SOPS-Neg) score of > 11, with at least one negative symptom of at least moderate severity (i.e., ≥ 3)
排除标准
- •meet criteria for a current or lifetime psychotic disorder;
- •have an IQ < 70;
- •a history of seizures or clinically significant neurological disorder that may contribute to prodromal symptoms.
- •have been involved in another treatment study in the past 4 weeks.
结局指标
主要结局
Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)
时间窗: 8 weeks
次要结局
- Reading the Mind in the Eyes Task (RMET)(4 weeks)
- Relationships Across Domains (RAD)(4 weeks)
- Scale of Prodromal Symptoms - Positive Subscale (SOPS-Pos)(8 weeks)
- Global Function: Role scale(8 weeks)
- Global Function: Social scale(8 weeks)
- Beck Scale for Suicidal Ideation (BSS)(4 weeks)
- Calgary Depression Scale for Schizophrenia(4 weeks)
- MATRICS Consensus Cognitive Battery (MCCB)(4 weeks)
- The Awareness of Social Inferences Test (TASIT)(4 weeks)
- Emotion Recognition - 40 (ER-40)(4 weeks)
- Interpersonal Reactivity Index (IRI)(4 weeks)
- Simulator Sickness Questionnaire (SSQ)(4 weeks)
- Functional Brain Imaging(4 weeks)
- Structural Brain Imaging(4 weeks)
研究者
George Foussias
Clinician Scientist
Centre for Addiction and Mental Health