Investigating the Neural Mechanisms of Repetitive Brain Stimulation With Invasive and Noninvasive Electrophysiology in Humans
概览
- 阶段
- 不适用
- 干预措施
- TMS
- 疾病 / 适应症
- Major Depressive Disorder
- 发起方
- Stanford University
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- TMS-iEEG change after one TBS session
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but clinical outcome is suboptimal, partially because investigators are missing biologically-grounded brain markers which show that TMS is modifying activity at the intended target in the brain. The goal of this proposal is to characterize the key markers of the brain's response to repeated doses of TMS with high resolution using invasive brain recordings in humans, and relate these brain markers to noninvasive recordings. These markers will improve the understanding of TMS and can be used to optimize and enhance clinical efficacy for depression and other psychiatric disorders.
详细描述
Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder, but remission rates are 20-40%, and ideal stimulation parameters are unknown. rTMS is thought to work by changing the synaptic strength of neurons. The ability of the brain to make these changes is referred to as plasticity. rTMS-induced changes are thought to build with successive treatment sessions, a process referred to as metaplasticity. While both plasticity and metaplasticity are well-established in single cell physiology, relevance to rTMS in humans remains unknown. To improve clinical efficacy, the investigators need to understand 1) the neural response to a single rTMS session (plasticity), 2) the neural response to repeated daily rTMS sessions (metaplasticity), and 3) whether computational models of plasticity based on single-cell physiology apply to human patients receiving rTMS for depression. Goals of the study are to 1) establish a detailed mechanistic understanding of the brain changes during current rTMS treatment; 2) identify clinically meaningful electrophysiological biomarkers for rTMS treatment; 3) establish a computational model to help predict both brain and clinical changes.
研究者
Corey Keller
Principal Investigator, Associate Professor
Stanford University
入排标准
入选标准
- •Men and women, ages 18 to 65
- •Medication-refractory epilepsy requiring phase II monitoring
- •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
- •Those with a contraindication for MRIs (e.g. implanted metal)
- •Any unstable medical condition
- •Neurological or uncontrolled medical disease
- •Active substance abuse
- •Currently pregnant or breastfeeding
研究组 & 干预措施
Sham TBS via transcranial magnetic stimulation
干预措施: TMS
TBS via transcranial magnetic stimulation
干预措施: TMS
Sham TBS via direct electrical stimulation
干预措施: Intracranial electrodes
TBS via direct electrical stimulation
干预措施: Intracranial electrodes
结局指标
主要结局
TMS-iEEG change after one TBS session
时间窗: 45 minutes
Change in evoked response measured after a single TBS session for active and sham, by resting state iEEG (intracranial EEG) and/or sEEG (stereo EEG).
次要结局
- ES-iEEG change between two sequential TBS sessions(45 minutes)
- ES-iEEG change after one TBS session(45 minutes)
- TMS-iEEG change between two sequential TBS sessions(45 minutes)