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临床试验/NCT05996900
NCT05996900招募中不适用

Investigating the Neural Mechanisms of Repetitive Brain Stimulation With Invasive and Noninvasive Electrophysiology in Humans

Stanford University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
49
试验地点
1
主要终点
TMS-iEEG change after one TBS session

研究概览

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

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

Sham Comparator

干预措施: TMS (Device)

TBS via transcranial magnetic stimulation

Active Comparator

干预措施: TMS (Device)

Sham TBS via direct electrical stimulation

Sham Comparator

干预措施: Intracranial electrodes (Device)

TBS via direct electrical stimulation

Active Comparator

干预措施: Intracranial electrodes (Device)

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Corey Keller

Principal Investigator, Associate Professor

Stanford University

研究点 (1)

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