Does Transcranial Direct Current Stimulation (tDCS) Enhance Outcomes From Computerised Cognitive Remediation in Patients With Schizophrenia?
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Progression score on cognitive training task.
研究概览
简要总结
The primary aim for the study is to determine whether transcranial direct current stimulation (tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims are to determine whether tDCS combined with CT causes larger transferable improvements on non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are maintained over time (i.e., maintenance effects).
Specific hypotheses are:
- CT combined with active tDCS will produce greater training gains on CT tasks compared to a similar control group receiving CT with sham tDCS.
- CT combined with active tDCS will produce greater generalisation effects on non-trained cognitive tasks compared to CT with sham tDCS.
- The cognitive improvements gained by patients from both interventions will be maintained over 1 month follow-up.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are 18 years of age or above.
- •Subjects meet criteria for a DSM -IV schizophrenia or schizoaffective disorder but with a stable mental status as demonstrated by a stable Positive and Negative Symptom Score (PANSS) score over a period of 2 weeks.
- •Subjects have had no medication changes in the 2 weeks prior to obtaining informed consent.
- •Subjects are right-handed.
- •Subjects able to give informed consent for the trial.
排除标准
- •Drug or alcohol abuse or dependence (preceding 3 months).
- •Concurrent anticonvulsant or long acting benzodiazepine medication, as these medications may interfere with the effects of tDCS.
- •Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
- •Clinically defined neurological disorder or insult, including history of seizures, cerebral aneurysm or trauma, significant head trauma with loss of consciousness for ≥ 30 minutes.
- •Subject has metal in the cranium, skull defects, or skin lesions on scalp at proposed electrode sites.
- •Female subject of child bearing age, sexually active and not using reliable contraception
研究组 & 干预措施
active tDCS and cognitive training
Transcranial direct current stimulation combined with cognitive training
干预措施: transcranial direct current stimulation (Device)
sham tDCD and cognitive training
Sham transcranial direct current stimulation combined with cognitive training
干预措施: transcranial direct current stimulation (Device)
结局指标
主要结局
Progression score on cognitive training task.
时间窗: Post treatment
次要结局
未报告次要终点
研究者
Melissa Pigot
Research Assistant
The University of New South Wales