Remediation of Auditory Recognition in Schizophrenia With Transcranial Direct Current Stimulation (tDCS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Auditory Tone Matching Task
研究概览
简要总结
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS), when combined with different forms of computer based training, improves the ability to discriminate small differences between sounds in people diagnosed with schizophrenia or schizoaffective disorder.
详细描述
This study uses an experimental procedure called transcranial direct current stimulation (tDCS). Little is known about how tDCS affects the brain or why some people diagnosed with schizophrenia or schizoaffective disorder have trouble with certain kinds of hearing. This study is being done to see if an experimental computer training program, when combined with tDCS, can help people to hear better. In tDCS, a small amount of electricity is passed through electrodes placed on the head that is able to stimulate the brain. By stimulating the brain, the investigators believe that the functioning of the brain can be altered. This study will test whether such stimulation of the brain, when done with computer training, can improve hearing ability and if this improvement helps in other ways, like detecting changes in someone's tone of voice or understanding other people's emotions better. The data being collected aims to better understand how the brain processes sounds and how tDCS affects the brain.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55
- •Primary diagnosis of Schizophrenia or schizoaffective disorder
- •English fluency
- •Willing/capable to provide informed consent
- •Auditory tone matching deficits
- •Receiving stable doses of antipsychotic medication(s) for at least 2 weeks
排除标准
- •Serious neurological disorder or medical condition/ treatment known to affect the brain. Neurological Disorder that affects the central nervous system (CNS), such as epilepsy, neurodegenerative disorders, movement disorders and sensory disorders.
- •Current or past history (within the last 6 months) of substance abuse or dependence (excluding nicotine)
- •Pregnancy or breastfeeding
- •Taking anticholinergic medication (e.g. Cogentin, Thorazine, Clozaril, thioridazine)
研究组 & 干预措施
Auditory remediation with active tDCS
Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
干预措施: Active Transcranial direct current stimulation (tDCS) (Device)
Auditory remediation with active tDCS
Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
干预措施: Auditory Remediation (Behavioral)
Auditory remediation with sham tDCS
Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
干预措施: Sham Transcranial direct current stimulation (tDCS) (Device)
Auditory remediation with sham tDCS
Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
干预措施: Auditory Remediation (Behavioral)
Control (computer games with sham tDCS)
Non-remediation, control computer activities (e.g. games) with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
干预措施: Sham Transcranial direct current stimulation (tDCS) (Device)
Control (computer games with sham tDCS)
Non-remediation, control computer activities (e.g. games) with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
干预措施: Control computer activities (Behavioral)
结局指标
主要结局
Auditory Tone Matching Task
时间窗: Change in performance from Baseline at completion of training (week 16)
Ability to match tones following brief delay
次要结局
- The Awareness of Social Inference Test (TASIT)(Change in performance from Baseline at completion of training (week 16))
- Auditory Emotion Recognition (AER) Task(Change in performance from Baseline at completion of training (week 16))
- ER-40(Change in performance from Baseline at completion of training (week 16))
- Auditory Mismatch Negativity (MMN)(Change in performance from Baseline at completion of training (week 16))
研究者
Daniel C. Javitt
Professor
New York State Psychiatric Institute