Theta Burst Modulation of Hippocampal-Cortical Rhythms in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in intracranial EEG after one TBS session
研究概览
简要总结
Schizophrenia - marked by delusions, hallucinations, and cognitive deficits - causes the most disability of any mental health condition, but existing treatments have significant side effect burden and are often ineffective. Disordered neural activity in the hippocampus likely contributes to schizophrenia symptoms, but to develop better therapies we need to understand whether hippocampal activity in schizophrenia can be systematically affected by non-invasive brain stimulation techniques like transcranial magnetic stimulation (TMS). This proposal will investigate the use of connectivity-guided theta burst brain stimulation to specifically target hippocampal function in schizophrenia, offering insights into fundamental hippocampal processes, schizophrenia pathophysiology, and potential avenues to use brain stimulation as a therapeutic tool in this devastating illness.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, ages 18 to 65 years
- •Medically intractable epilepsy requiring phase II monitoring (intracranial EEG arms only)
- •DSM-V diagnosis of schizophrenia spectrum Axis I disorders including delusional disorder, brief psychotic disorder, schizophreniform disorder, schizophrenia, schizoaffective disorder (non-invasive TMS-EEG arms only).
- •Must have intellectual capacity to ensure adequate comprehension of the study and potential risks involved in order to provide informed consent
- •No current or history of major neurological disorders other than epilepsy.
排除标准
- •DSM5 diagnosis of intellectual disability
- •Significant head injury
- •Active suicidal ideation or history of suicide attempt within the past 1 year.
- •Medical illness affecting brain structure or function, or other uncontrolled or unstable medical condition.
- •Pregnancy or postpartum (<6 weeks after delivery or miscarriage)
- •Inability to provide informed consent
- •Active substance abuse other than alcohol or cannabis within the past 1 year
- •Psychotic illness with a temporal relation to substance use or head injury
- •Those with a contraindication for MRIs or TMS (e.g. implanted metal).
结局指标
主要结局
Change in intracranial EEG after one TBS session
时间窗: 45 minutes
Change in spontaneous oscillatory EEG power from before to after application of one TBS session, for active and sham stimulation, as measured via intracranial recording electrodes (iEEG).
Change in scalp EEG after one TBS session
时间窗: 45 minutes
Change in spontaneous oscillatory EEG power from before to after application of one TBS session, for active and sham stimulation, as measured via scalp recording electrodes (scalp electroencephalography).
次要结局
- Change in TMS-provoked EEG power(45 minutes)
- Change in electrical stimulation provoked iEEG power(45 minutes)
研究者
Ethan Andrew Solomon
Postdoctoral Scholar
Stanford University