Optimized Methods for Measuring Brain Excitability in Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Changes in Posterior EL-TEP Amplitude after spTMS
研究概览
简要总结
The goal of this study is to improve depression treatment by establishing reliable prefrontal excitability markers through Targeting with Automated Real-time Guidance for Enhancing TEPs (TARGET).
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
- Triple (Participant, Investigator, 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
- 是
入选标准
- •Men and women, ages 18 to 65
- •Diagnosis of major depressive disorder, assessed through a Structured Clinical Interview for DSM-5 (SCID-5)
- •In a current depressive episode, assessed through a Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)
- •Moderate-to-severe depression as indicated by a score between 11-20 on the Quick Inventory of Depressive Symptoms (QIDS)
- •Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
- •No current or history of neurological disorders
- •No seizure disorder or risk of seizures
- •Neurosurgical patients: Men and women ages 18-65 with medication-refractory epilepsy who are admitted for phase II intracranial monitoring to detect a seizure focus will be considered appropriate for this study. Participants must have the intellectual capacity to understand the consent process and agree to the study.
排除标准
- •Those with a contraindication for MRIs (e.g. implanted metal)
- •History of head trauma with loss of consciousness
- •History of seizures or on medications that reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium)
- •Neurological or uncontrolled medical disease
- •Any unstable medical condition
- •Active substance abuse
- •Diagnosis of psychotic or bipolar disorder
- •A prior history of Electroconvulsive Therapy (ECT) failure
- •History of suicide attempt in the past year
- •Currently pregnant or breastfeeding
- •Repetitive Transcranial Magnetic Stimulation (rTMS) treatment in the past six months
研究组 & 干预措施
Active TMS, Sham TMS with iEEG
Neurosurgical participants receive both active single-pulse Transcranial Magnetic Stimulation (TMS) and sham single-pulse TMS delivered to predefined dlPFC sites while undergoing intracranial EEG recording. The order of active and sham stimulation is randomized.
干预措施: Active Single-Pulse TMS (Device)
Active TMS, Sham TMS with iEEG
Neurosurgical participants receive both active single-pulse Transcranial Magnetic Stimulation (TMS) and sham single-pulse TMS delivered to predefined dlPFC sites while undergoing intracranial EEG recording. The order of active and sham stimulation is randomized.
干预措施: Sham Single-Pulse TMS (Device)
Active TMS, Sham TMS with iEEG
Neurosurgical participants receive both active single-pulse Transcranial Magnetic Stimulation (TMS) and sham single-pulse TMS delivered to predefined dlPFC sites while undergoing intracranial EEG recording. The order of active and sham stimulation is randomized.
干预措施: Intracranial EEG (iEEG) Recording (Other)
Sham TMS, Active TMS with iEEG
Neurosurgical participants receive sham single-pulse TMS followed by active single-pulse TMS at predefined dlPFC sites during intracranial EEG recording. The order of stimulation conditions is randomized.
干预措施: Active Single-Pulse TMS (Device)
Sham TMS, Active TMS with iEEG
Neurosurgical participants receive sham single-pulse TMS followed by active single-pulse TMS at predefined dlPFC sites during intracranial EEG recording. The order of stimulation conditions is randomized.
干预措施: Sham Single-Pulse TMS (Device)
Sham TMS, Active TMS with iEEG
Neurosurgical participants receive sham single-pulse TMS followed by active single-pulse TMS at predefined dlPFC sites during intracranial EEG recording. The order of stimulation conditions is randomized.
干预措施: Intracranial EEG (iEEG) Recording (Other)
Optimized TMS, Non-optimized TMS with EEG
Participants receive both TARGET optimized single-pulse TMS and non-optimized (open-loop) single-pulse TMS to the dlPFC while undergoing concurrent scalp EEG. The sequence of optimized and non-optimized stimulation is randomized.
干预措施: TARGET-optimized TMS (Device)
Optimized TMS, Non-optimized TMS with EEG
Participants receive both TARGET optimized single-pulse TMS and non-optimized (open-loop) single-pulse TMS to the dlPFC while undergoing concurrent scalp EEG. The sequence of optimized and non-optimized stimulation is randomized.
干预措施: Non-optimized (Open-Loop) TMS (Device)
Optimized TMS, Non-optimized TMS with EEG
Participants receive both TARGET optimized single-pulse TMS and non-optimized (open-loop) single-pulse TMS to the dlPFC while undergoing concurrent scalp EEG. The sequence of optimized and non-optimized stimulation is randomized.
干预措施: EEG Recording (Other)
Non-optimized TMS, Optimized TMS with EEG
Participants receive non-optimized (open-loop) single-pulse TMS followed by TARGET optimized single-pulse TMS to the dlPFC with concurrent scalp EEG. The order of stimulation conditions is randomized.
干预措施: TARGET-optimized TMS (Device)
Non-optimized TMS, Optimized TMS with EEG
Participants receive non-optimized (open-loop) single-pulse TMS followed by TARGET optimized single-pulse TMS to the dlPFC with concurrent scalp EEG. The order of stimulation conditions is randomized.
干预措施: Non-optimized (Open-Loop) TMS (Device)
Non-optimized TMS, Optimized TMS with EEG
Participants receive non-optimized (open-loop) single-pulse TMS followed by TARGET optimized single-pulse TMS to the dlPFC with concurrent scalp EEG. The order of stimulation conditions is randomized.
干预措施: EEG Recording (Other)
结局指标
主要结局
Changes in Posterior EL-TEP Amplitude after spTMS
时间窗: Baseline, end of spTMS (6 hours)
Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 6 hours of either active or sham spTMS between optimized and non-optimized stimulation conditions in the posterior dlPFC.
Changes in Anterior EL-TEP Amplitude after single-pulse TMS (spTMS)
时间窗: Baseline, end of spTMS (6 hours)
Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 6 hours of either active or sham spTMS between optimized and non-optimized stimulation conditions in the anterior dlPFC.
Changes in intracranial TMS-Evoked Potential (iTEP) Amplitude after TMS-iEEG
时间窗: Baseline, end of spTMS (20 minutes)
Changes in the interaction between gyral/sulcal targets and coil angles (45 vs 90 degrees) on local dlPFC iTEP amplitude.
次要结局
未报告次要终点
研究者
Corey Keller
Associate Professor
Stanford University