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临床试验/NCT05857137
NCT05857137
进行中(未招募)
不适用

Investigational TMS Study of Cognitive Impairment in Early Psychosis

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 20 人2023年4月4日
适应症Psychosis

概览

阶段
不适用
干预措施
Active TMS
疾病 / 适应症
Psychosis
发起方
Massachusetts General Hospital
入组人数
20
试验地点
1
主要终点
Working memory accuracy
状态
进行中(未招募)
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2023年4月4日
结束日期
2026年7月30日
最后更新
2个月前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Principal Investigator
主要研究者

Hamdi Eryilmaz, PhD

Assistant Professor

Massachusetts General Hospital

入排标准

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

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

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.

研究点 (1)

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