Investigational TMS Study of Cognitive Impairment in Early Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Working memory accuracy
研究概览
简要总结
The main goal of this study is to investigate the neural mechanisms of working memory function in patients with early psychosis using Transcranial Magnetic Stimulation (TMS) in conjunction with functional MRI. TMS is a noninvasive method used to modulate brain activity via changing magnetic fields applied over the surface of the scalp.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of psychosis, psychosis not otherwise specified, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder with psychosis, and schizophreniform disorder within first ten years of onset of psychotic symptoms.
- •Ability to provide informed consent
排除标准
- •TMS incompatibility including metallic implants in head and neck, cardiac pacemakers, history of seizures, pregnancy.
- •MRI-incompatibility including implanted aneurism clips, cardiac pacemakers, metal implants, intrauterine devices, tattoos containing metal ink, pregnancy, and claustrophobia
- •Severe substance abuse within 3 months (nicotine allowed)
- •Unstable medical or neurologic illness that would preclude participation in study procedures
研究组 & 干预措施
Active TMS
Participants will receive single-session administration of TMS. Functional MRI will be acquired before and immediately after the intervention.
干预措施: Active TMS (Device)
Placebo TMS
Participants will also receive single session administration of placebo TMS (at least two days apart from the day of the active TMS). Functional MRI will be acquired before and immediately after the intervention.
干预措施: Placebo TMS (Device)
结局指标
主要结局
Working memory accuracy
时间窗: 2 hours
Accuracy at high memory loads during performance of the Sternberg Item Recognition Paradigm will be assessed before and after the TMS interventions.
Reaction time during working memory
时间窗: 2 hours
Reaction time during performance of the Sternberg Item Recognition Paradigm will be assessed before and after the TMS interventions.
Resting state functional connectivity between the left inferior parietal lobule and the regions of the frontoparietal control network
时间窗: 2 hours
Functional connectivity between left inferior parietal lobule and dorsolateral prefrontal cortex will be computed during resting state acquired before and after the TMS interventions.
Resting state functional connectivity within the default mode network
时间窗: 2 hours
Functional connectivity between left inferior parietal lobule and other regions of the default mode network (including the posterior cingulate cortex and the medial prefrontal cortex) will be computed during resting state acquired before and after the TMS interventions.
次要结局
未报告次要终点
研究者
Hamdi Eryilmaz, PhD
Assistant Professor
Massachusetts General Hospital