Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Questionnaire for Psychotic Experiences (QPE)
研究概览
简要总结
The present study aims to investigate whether transcranial direct current stimulation (tDCS) reduces auditory hallucinations in patients with psychosis. In addition, the neuronal changes of tDCS will be examined.
详细描述
The majority of patients with psychosis experience hallucinations, particularly auditory hallucinations are frequent. The hallucinations often leads to massive distress and impairments in social functioning and sometimes even order patients to commit acts of violence against themselves or others. The standard treatment for auditory hallucinations is antipsychotic medication. However, side-effects can be severe and about 25-30% of the patients do not respond to the medication. Transcranial direct current stimulation is a non-invasive brain stimulation technique, which modulates cortical excitability in a pain-free free with mild transient adverse effects, if any. Typically, cortical excitability underneath the anode is boosted while cathodal stimulation has inhibitory effects. Previous studies found that 2 daily sessions of 20 min tDCS for five subsequent days may reduce auditory hallucinations. Investigators want to further assess the efficacy of tDCS in sample that is large enough to detect medium to large effects. In addition, investigators want to investigate the neural mechanisms that underlie the tDCS treatment by examining various neuroimaging parameters before, immediately after treatment, and 3 months after treatment.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with schizophrenia spectrum disorder or other psychotic disorder
- •Frequent auditory hallucinations (at least 5 times a week).
- •Patients are on a stable dose of antipsychotic medication (which can also be zero) for at least 2 weeks.
- •Mentally competent for informed consent.
- •Provided informed consent.
排除标准
- •Metal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing)
- •History of seizures, or a history of seizures in first-degree relatives.
- •History of eye trauma with a metal object or professional metal workers
- •History of brain surgery, brain infarction, head trauma, cerebrovascular accident, broken skull, brain tumour, heart disease, cardiac pacemaker.
- •Skin disease on the scalp on the position of the tDCS electrodes
- •Coercive treatment based on a judicial ruling
- •Pregnancy in female patients
研究组 & 干预措施
real tDCS
DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
干预措施: DC Stimulator PLUS (NeuroConn) (Device)
sham tDCS
DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
干预措施: DC Stimulator PLUS (NeuroConn) (Device)
结局指标
主要结局
Questionnaire for Psychotic Experiences (QPE)
时间窗: Change from Baseline to immediately after treatment and 3 months after treatment
Measure for severity of hallucinations
Auditory Hallucination Rating Scale (AHRS)
时间窗: Change from Baseline to immediately after treatment and 3 months after treatment
Self-report measure for severity of hallucinations; consists of seven items; Sum can range from 2 to 41; higher values indicate more severe hallucinations
Hallucinations App
时间窗: Continuously between baseline and 3 months after treatment
iPhone/iPod application for self-ratings of auditory hallucinations
Hallucination Change Scale (HCS)
时间窗: Change from Baseline to immediately after treatment and 3 months after treatment
Measure for changes in severity of auditory hallucinations
Positive and Negative Syndrome Scale (PANSS)
时间窗: Change from Baseline to immediately after treatment and 3 months after treatment
Measure for positive and negative symptoms in psychotic disorders
Hallucination Change Scale (HCS)
时间窗: Change from Baseline to immediately after treatment
Measure for changes in severity of auditory hallucinations; participants rated in percent how much their symptoms had improved (or worsened). The range is thus -100 (symptoms reduced by 100%) to +100 (symptoms worsened by 100%)
次要结局
- Stroop task(Change from Baseline to immediately after treatment and 3 months after treatment)
- Trailmaking test A and B(Change from Baseline to immediately after treatment and 3 months after treatment)
- Expectations Questionnaire(Change from Baseline to immediately after treatment and 3 months after treatment)
- BOLD (Blood Oxygenation Level Dependent signal) response during resting state(Change from Baseline to immediately after treatment and 3 months after treatment)
- Adverse Effects Questionnaire(The questionnaire is completed after each tDCS session. That is, twice on each day of the five day treatment program)
- Global Assessment of Functioning(Change from Baseline to immediately after treatment and 3 months after treatment)
- Shape, size, and integrity of gray and white matter structures in the brain(Change from Baseline to immediately after treatment and 3 months after treatment)
- GABA and glutamate levels in the dorsolateral prefrontal cortex and peri-Sylvian regions(Change from Baseline to immediately after treatment and 3 months after treatment)
- BOLD response during dichotic listening paradigm(Change from Baseline to immediately after treatment and 3 months after treatment)
- White matter structure and connectivity(Change from Baseline to immediately after treatment and 3 months after treatment)
- Dichotic listening paradigm(Change from Baseline to immediately after treatment and 3 months after treatment)
- The Clinical Global Impressions Scale - Severity(Change from Baseline to immediately after treatment and 3 months after treatment)
- Positive and Negative Syndrome Scale (PANSS)(Change from Baseline to immediately after treatment and 3 months after treatment)
- Stroop Task(Change from Baseline to immediately after treatment and 3 months after treatment)
- Trailmaking Test B(Change from Baseline to immediately after treatment and 3 months after treatment)
- Apathy Evaluation Scale(Before, immediately after treatment, and at 3 month follow-up)
- Global Assessment of Functioning - S(Change from Baseline to immediately after treatment and 3 months after treatment)
- Dichotic Listening Paradigm(Change from Baseline to immediately after treatment and 3 months after treatment)
- Dichotic Listening Laterality Index(Change from Baseline to immediately after treatment and 3 months after treatment)
研究者
Marco Hirnstein
PhD
University of Bergen