Real-time fMRI Feedback as a Tool to Mitigate Auditory Hallucinations in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- rt-fMRI neurofeedback from STG
研究概览
简要总结
Auditory hallucinations in schizophrenia are one of the major symptoms of this disease and a major source of psychological discomfort. They are often difficult or impossible to treat with existing methods. This study will test the use of real-time fMRI neurofeedback to mitigate auditory verbal hallucinations in patients whose hallucinations are resistant to medication. Half of the patients will receive real time fMRI neurofeedback from a brain region involved in auditory hallucinations and half will receive it from motor cortex.
详细描述
Auditory verbal hallucinations (AH) have long been a hallmark of schizophrenia (SZ) and are one of its major diagnostic features. They are difficult to manage with existing treatment options. Here, neurofeedback will be used to regulate the superior temporal gyrus (STG) activation which will not only lead to activation changes in the STG, but also to changes in the default mode network (DMN).
The investigators will study SZ patients with medication resistant AH in the rt-fMRI intervention arm and in the sham-rt-fMRI arm. In both arms, the task and the rt-fMRI session structure will be identical. The SZ-intervention group will receive feedback from the STG while SZ-sham group will receive feedback from the motor cortex. In addition, 2 functional fMRI tasks will examine the effect of rt-fMRI neurofeedback and of sham-rt-fMRI on brain response.
The investigators will randomly assign 48 SZ patients to either SZ-intervention (n=24) or SZ-sham-rtfMRI (n=24). The STG targeted neurofeedback is predicted to bring changes in brain regions involved in AH (STG and DMN) in SZ-intervention group only. The R61 GO criterion will be BOLD signal reduction in the STG, and resting state connectivity reduction between MPFC-PCC, post rt-fMRI-feedback in SZ-intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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
- •a diagnosis of schizophrenia or schizoaffective disorder based on SCID interview (DSM-5) and
- •the presence of auditory hallucinations (PANSS, item 3, score ≥4) with frequency of AH being at least once daily;
- •age between 18-55 years;
- •estimated IQ of above 80 as measured by WASI;
- •English as the primary language;
- •right-handed as determined by the Edinburgh Handedness Inventory (scoring + 60; Oldfield, 1971);
- •an ability and desire to participate in the testing program as explained by an experimenter and confirmed with a written consent form.
排除标准
- •history of ECT for the last 5 years;
- •history of neurological illness or a traumatic head injury, defined as loss of consciousness for more than 5 minutes and/or structural sequelae following head trauma;
- •history of severe or moderate alcohol (AUD) or substance use disorder (SUD) in the past five years, or mild AUD or SUD within the last year, according to DSM-5;
- •the use, in the preceding year of steroids or barbiturates, which can affect cognitive function;
- •hearing, vision or upper body impairment
- •alcohol use in the last 24 hours;
结局指标
主要结局
rt-fMRI neurofeedback from STG
时间窗: 1-2 weeks, post rt-fMRI session
changes in BOLD activation in STG
次要结局
- rt-fMRI neurofeedback from mPFC(1-2 weeks, post rt-fMRI session)
研究者
Margaret Niznikiewicz
associate professor; lab director
Harvard Medical School (HMS and HSDM)