The Neural, Behavioural, and Cognitive Outcomes of Transcranial Direct Current Stimulation (tDCS) for Persistent Auditory Verbal Hallucinations in Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in auditory hallucination severity measured by the Psychotic Symptom Rating Scale (PSYRATS)
研究概览
简要总结
Many individuals with schizophrenia struggle with auditory verbal hallucinations (AVHs). In some cases, these AVHs can be resistant to medication treatment. Previous research has found that transcranial direct current stimulation (tDCS) can be helpful in treating symptoms in individuals with other psychiatric disorders, such as depression. This study will assess if tDCS is effective in treating AVHs in individuals with schizophrenia. tDCS is a non-invasive form of brain stimulation which uses a weak current to temporarily excite or inhibit underlying cortical regions with small electrodes placed on the scalp. tDCS has been found to improve mental processes, including attention and memory function. In addition to examining the effect of tDCS on AVHs, this study will assess the effects of tDCS on mood as well as brain electrical activity with electroencephalogram (EEG) recordings. As an additional component, participants will be invited to participate in neuroimaging. Using magnetic resonance imaging (MRI), brain activity and structure will be examined before and after tDCS. tDCS will be administered twice daily for 5 consecutive days for a total of 10 sessions. These study findings will contribute to the understanding of the impact of tDCS on AVHs, and will also increase knowledge of sound and memory/cognitive processing in individuals with schizophrenia.
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
- 是
入选标准
- •Primary diagnosis of schizophrenia or schizoaffective disorder
- •Clinically stable (discretion of psychiatrist)
- •Consistent history of AVHs over the course of illness
- •>3 AVHs per week
- •Positive and Negative Syndrome Scale (PANSS) score of >3
- •Primary medications limited to one of the atypical antipsychotics (medications stabilized for 4 weeks prior to enrollment)
排除标准
- •Experiencing an acute psychotic episode
- •Current drug/alcohol dependence
- •Significant medical illness & mental retardation/learning disability
- •Extra-pyramidal symptoms resulting in disordered movement
- •Abnormal audiometric assessment (thresholds for pure tones >25 dB)
- •History of significant neurological issues & head injuries/concussions resulting in loss of consciousness for >5 minutes
- •Healthy Controls - Inclusion Criteria:
- •In good physical health
- •No history of serious mental health issues
- •Healthy Controls - Exclusion Criteria:
- •Personal history of psychiatric disorder
- •Family history of schizophrenia in first degree relatives & history of mental health issues in first degree relatives that required extensive treatment or hospitalization
- •Current/history of substance abuse
- •Significant medical illness
- •Extra-pyramidal symptoms resulting in movement disorder
- •Abnormal audiometric assessment (thresholds for pure tones >25 dB)
- •Significant neurological issues & head injuries/concussions resulting in loss of consciousness for >5 minutes
结局指标
主要结局
Change in auditory hallucination severity measured by the Psychotic Symptom Rating Scale (PSYRATS)
时间窗: Baseline, after 2nd tDCS session on days 1, 3, and 5, and follow-up (within a week of completing tDCS)
The PSYRATS is a multidimensional measure of auditory hallucinations, including 11 items rated on five-point (0-4) scales (total score range 0-44). Symptoms are rated over the last week, with higher scores reflecting more severe symptoms. The dimensions assessed are frequency, duration, location, loudness, beliefs about origin, negative content, intensity of negative content, amount of distress, intensity of distress, disruption of life and control.
次要结局
- Change in Electroencephalography (EEG) - Resting-State Theta Power(3 weeks (baseline to follow-up))
- Change in Electroencephalography (EEG) - Mismatch Negativity (MMN)(3 weeks (baseline to follow-up))
- Change in Cambridge Neuropsychological Test Automated Battery (CANTAB) Schizophrenia Battery(3 weeks (baseline to follow-up))
- Change in Social Cognition - Social Attribution Task(3 weeks (baseline to follow-up))
- Change in Electroencephalography (EEG) - Resting-State Alpha Power(3 weeks (baseline to follow-up))
- Change in Beliefs about Voices Questionnaire-Revised (BAVQ-R) Scores(3 weeks (baseline to follow-up))
- Change in Voice Power Differential Scale (VPDS) Scores(3 weeks (baseline to follow-up))
- Change in Voices Acceptance and Action Scale (VAAS) Scores(3 weeks (baseline to follow-up))
- Change in Electroencephalography (EEG) - Resting-State Gamma Power(3 weeks (baseline to follow-up))
- Change in Brain Magnetic Resonance Spectroscopy (MRS)(3 weeks (baseline to follow-up))
- Change in Electroencephalography (EEG) - Resting-State Beta Power(3 weeks (baseline to follow-up))
- Change in Electroencephalography (EEG) - P50(3 weeks (baseline to follow-up))
- Change in Brain Functional Magnetic Resonance Imaging (fMRI) - Resting-State(3 weeks (baseline to follow-up))
- Change in Brain Functional Magnetic Resonance Imaging (fMRI) - Mismatch Negativity (tonal)(3 weeks (baseline to follow-up))
- Change in Electroencephalography (EEG) - Resting-State Delta Power(3 weeks (baseline to follow-up))
研究者
Dr. Verner Knott
Senior Scientist
University of Ottawa