Optimizing Depression Treatment Through Sleep-state Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in Baseline TMS-EEG after iTBS
研究概览
简要总结
The goal of this study is to establish the feasibility, tolerability, and preliminary efficacy of sleep-state transcranial magnetic stimulation (TMS) for enhancing plasticity in depression treatment.
详细描述
Healthy control participant cohort funded through K99MH141192 and depressed patient cohort funded through K99MH141192 and UM1TR004921.
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, Investigator)
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
- •Adults ages 18-65 years
- •Current Major Depressive Disorder (MDD) diagnosis
- •Failed ≥1 antidepressant medication
- •Moderate-to-severe depression
- •Stable antidepressant medication dose for ≥ 6 weeks prior to enrollment
- •Healthy control participants are adults ages 18-65 years without current MDD symptoms, not taking antidepressant or antipsychotic medications, and without major psychiatric, neurological, substance use, medical conditions affecting brain function, or TMS/MRI contraindications.
排除标准
- •Intellectual disability
- •Significant head injury/neurological disorder
- •Pregnancy or postpartum
- •TMS/MRI contraindications
- •Active substance use/suicidal ideation
研究组 & 干预措施
Active TMS, Sham TMS
Participants will receive 2 sessions of Transcranial Magnetic Stimulation (TMS) delivered using standard intermittent theta-burst (iTBS) parameters (600 pulses, 3 min, 120% rMT). Participants will receive, on separate sessions, either active or sham iTBS delivered during wakefulness and/or NREM sleep stages while recording with Electroencephalography (EEG). Participants will perform the N-back task and Multi-source Interference Task (MSIT) during each session to measure working memory and cognitive control performance.
干预措施: TMS (Device)
Sham TMS, Active TMS
Participants will receive 2 sessions of Transcranial Magnetic Stimulation (TMS) delivered during using standard intermittent theta-burst (iTBS) parameters (600 pulses, 3 min, 120% rMT). Participants will receive, on separate sessions, either active or sham iTBS delivered during wakefulness and/or NREM sleep stages while recording with Electroencephalography (EEG). Participants will perform the N-back task and Multi-source Interference Task (MSIT) during each session to measure working memory and cognitive control performance.
干预措施: TMS (Device)
结局指标
主要结局
Change in Baseline TMS-EEG after iTBS
时间窗: Baseline, end of iTBS (3 minutes)
Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 3 minutes of either active or sham iTBS in each session to assess cortical excitability and plasticity measures. 1\) tbs; 2) sleep (cortical excitability and plasticity measures) in both active and sham.
Change in Baseline TMS-EEG after NREM Sleep
时间窗: Baseline, end of sleep stage (3 hours)
Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 3 hours of NREM sleep in each session to assess cortical excitability and plasticity measures.
Change in N-back Accuracy Performance
时间窗: Baseline, end of sleep stage (3 hours)
N-back task (15-min) measures working memory performance and accuracy will be determined by the number of correct responses to the stimulus. Change in accuracy performance will be assessed before and after NREM sleep.
Change in N-back Reaction Time Performance
时间窗: Baseline, end of sleep stage (3 hours)
N-back task (15-min) measures working memory performance and reaction time will be determined by the time it takes for the participant to respond to the stimulus. Change in reaction time performance will be assessed before and after NREM sleep.
Change in MSIT Accuracy Performance
时间窗: Baseline, end of sleep stage (3 hours)
Multi-source Interference Task (MSIT; 15-min) measures cognitive control performance and accuracy will be determined by the number of correct responses to the stimulus. Change in accuracy performance will be assessed before and after NREM sleep.
Change in MSIT Reaction Time Performance
时间窗: Baseline, end of sleep stage (3 hours)
Multi-source Interference Task (MSIT; 15-min) measures cognitive control performance and reaction time will be determined by the time it takes for the participant to respond to the stimulus. Change in reaction time performance will be assessed before and after NREM sleep.
Change in Baseline TMS-EEG after iTBS
时间窗: Baseline, end of iTBS (3 minutes)
Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 3 minutes of either active or sham iTBS in each session to assess cortical excitability and plasticity measures. 1\) tbs; 2) sleep (cortical excitability and plasticity measures) in both active and sham.
Change in Baseline TMS-EEG after NREM Sleep
时间窗: Baseline, end of sleep stage (3 hours)
Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 3 hours of NREM sleep in each session to assess cortical excitability and plasticity measures.
Change in N-back Accuracy Performance
时间窗: Baseline, end of sleep stage (3 hours)
N-back task (15-min) measures working memory performance and accuracy will be determined by the number of correct responses to the stimulus. Change in accuracy performance will be assessed before and after NREM sleep.
Change in N-back Reaction Time Performance
时间窗: Baseline, end of sleep stage (3 hours)
N-back task (15-min) measures working memory performance and reaction time will be determined by the time it takes for the participant to respond to the stimulus. Change in reaction time performance will be assessed before and after NREM sleep.
Change in MSIT Accuracy Performance
时间窗: Baseline, end of sleep stage (3 hours)
Multi-source Interference Task (MSIT; 15-min) measures cognitive control performance and accuracy will be determined by the number of correct responses to the stimulus. Change in accuracy performance will be assessed before and after NREM sleep.
Change in MSIT Reaction Time Performance
时间窗: Baseline, end of sleep stage (3 hours)
Multi-source Interference Task (MSIT; 15-min) measures cognitive control performance and reaction time will be determined by the time it takes for the participant to respond to the stimulus. Change in reaction time performance will be assessed before and after NREM sleep.
次要结局
- Changes in Pittsburgh Sleep Quality Index (PSQI) Scores(After each sleep session (3 hours))
- Changes in Treatment Tolerability(After each sleep session (3 hours))
研究者
Umair Hassan
Postdoctoral Researcher in Department of Psychiatry and Behavioral Sciences
Stanford University