Treat Refractory Auditory Hallucinations in Schizophrenia Patients With fMRI-guided Neurofeedback: a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity
研究概览
简要总结
The INTRUDE trial aims at assessing the efficacy of an fMRI-based neurofeedback procedure on drug-resistant auditory hallucinations. Hallucinations are complex and transient mental states associated with subtle and brain-wide patterns of activity for which we were recently able to validate an fMRI multivariate decoder. Based on this progress, we can track patients' hallucinatory status using real-time fMRI. We will test whether schizophrenia patients with drug-resistant hallucinations can be trained to maintain the brain state associated with a no-hallucination condition using appropriate strategies and thus reduce overall severity. We will refer to a double-blind randomized placebo-controlled design. A total of 86 patients will be enrolled and equally split in an active neurofeedback group (n=43) and a sham group (n=43), matched for sex, age and PANSS scores. Each patient will benefit from 4 runs of either active or sham neurofeedback. The primary outcome measure will be the mean decrease of AHRS scores relative to baseline, and at 1 month post-treatment. We expect significant clinical benefits from fMRI-based neurofeedback on drug-resistant hallucinations compared with the sham group.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia (according to the DSM-5 classification)
- •Frequent auditory hallucinations (SAPS item #1 ≥ 4)
- •Stable medication for at least 30 days
- •Absence of chronic neurological disorder (including seizure)
- •Able to provide free written consent to participate in the research
排除标准
- •Pregnancy
- •Contraindication to MRI scan
- •Claustrophobia
- •No social insurance
研究组 & 干预措施
Sham
The visual feedback will correspond to random instructions independently of the fMRI signal.
干预措施: Sham neurofeedback procedure (Other)
Active
The visual feedback will correspond to instructions, adapted to the current hallucinatory state and decoded online from the fMRI signal.
干预措施: Active neurofeedback procedure (Other)
结局指标
主要结局
Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity
时间窗: 1 month after treatment
AHRS will be measured at t0 (randomization) and at 1 month after treatment Minimum score is 2, maximum score is 41, higher score indicates more severe symptoms.
次要结局
- Change from baseline Questionnaire for Psychotic Experiences (QPE) measure for severity of hallucinations(1 month after treatment)
- Changes in global functioning relative to baseline(1 month after treatment)
- Changes in quality of life relative to baseline(1 month after treatment)
- Change from baseline Visual analogue scale (VAS) measure for severity of hallucinations(1 month after treatment)
- Changes in functional MRI markers relative to baseline(1 month after treatment)
- Change from baseline Simplified Acute Physiology Score (SAPS) measure for severity of hallucinations(1 month after treatment)
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) measure of hallucinations severity(1 month after treatment)
- Changes in structural MRI markers relative to baseline(1 month after treatment)