Early TMS-EEG Potentials as Biomarkers for Personalized Neuromodulation in Treatment-Resistant Depression (R61 Phase)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percent Change in Early Local TMS-Evoked Potential (EL-TEP) Amplitude
研究概览
简要总结
This study tests whether a brain stimulation treatment for depression called intermittent theta burst stimulation (iTBS) can be improved by tailoring it to each individual. A type of brain signal measured with electroencephalography (EEG) after a single pulse of brain stimulation, called an early local TMS-evoked potential (EL-TEP), is used to identify which stimulation settings work best for each participant. The investigators will compare individualized (personalized) iTBS settings to standard (non-personalized) settings and to inactive (sham) stimulation. Participants are adults with treatment-resistant depression.
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, Care Provider, 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
- 否
入选标准
- •Aged 18-65 years
- •Clinical diagnosis of Major Depressive Disorder (MDD), confirmed by structured clinical interview
- •Current moderate-to-severe depressive episode (MADRS score ≥ 20)
- •Moderate-to-severe treatment resistance, assessed using the Maudsley Staging Method
- •Able to comprehend English sufficiently to complete study procedures and assessments
- •Able to maintain stable antidepressant regimen or remain medication-free for at least 4 weeks prior to and during the study
排除标准
- •Primary psychiatric diagnosis other than MDD
- •Contraindications to MRI (e.g., implanted metal)
- •Conditions or medications that may increase risk associated with TMS
- •Prior exposure to repetitive TMS (rTMS)
- •Non-response to electroconvulsive therapy (ECT)
- •History of psychosurgery for depression
- •High suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
研究组 & 干预措施
Personalized iTBS
Participants receive 10 sessions of iTBS using individually selected pulse count and intensity parameters identified during a prior screening phase as producing the greatest suppression of the EL-TEP biomarker.
干预措施: Personalized iTBS (Device)
Non-Personalized iTBS
Participants receive 10 sessions of iTBS using standard fixed parameters (1800 pulses, 120% resting motor threshold).
干预措施: Non-Personalized iTBS (Device)
Sham iTBS
Participants receive 10 sessions of sham iTBS, matched in timing and scalp sensation to active stimulation using a shielded coil and scalp electrodes.
干预措施: Sham iTBS (Device)
结局指标
主要结局
Percent Change in Early Local TMS-Evoked Potential (EL-TEP) Amplitude
时间窗: Baseline, end of 10 iTBS sessions within a single testing day (10 hours)
EL-TEP amplitude is the peak-to-trough amplitude of the early (20-60 ms) EEG response recorded over the left dorsolateral prefrontal cortex following single TMS pulses. Percent change is calculated from pre-iTBS to post-iTBS for each stimulation condition.
次要结局
- Acute EL-TEP Suppression Following Each Screened iTBS Condition(Baseline, end of each iTBS session during the screening phase (3 screening days, up to approximately 3 weeks))
- Trajectory of EL-TEP Change Across Multiple Sessions Within a Testing Day(Baseline, before and after sessions 1, 2, 3, and 10 within a single testing day (10 hours))
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score(Baseline, end of each testing day (up to approximately 7 weeks))
- Change in Quick Inventory of Depressive Symptomatology (QIDS) Score(Baseline, end of each testing day (up to approximately 7 weeks))
- Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) Score(Baseline, end of each testing day (up to approximately 7 weeks))
- Change in N-Back Task Performance(Baseline, end of each testing day (up to approximately 7 weeks))
- Change in Multi-Source Interference Task (MSIT) Performance(Baseline, end of each testing day (up to approximately 7 weeks))
- Change in Affective Processing Task Performance(Baseline, end of each testing day (up to approximately 7 weeks))
研究者
Corey Keller
Associate Professor
Stanford University