Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- EEG parameters to asses the change
研究概览
简要总结
Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. In fact, there is an FDA-approved depression protocol to stimulate the dorsolateral prefrontal cortex (dlPFC). Its efficacy and safety have improved significantly with continued research and clinical experience. However, it is not known how to identify potential patients who would benefit most from treatment.
The primary goal of this study is to determine if changes in specific electroencephalogram (EEG) parameters after treatment can predict whether patients are responders or non-responders to rTMS. The second objective is to analyze changes in the functional connectivity of specific brain regions in responders compared to non-responders.
The hypothesis is that through rTMS treatment, investigators will be able to increase the activity in the frontal region that includes the dorsolateral prefrontal cortex (DLPFC). Scalp EEG signals will be processed in order to compare EEG brain connectivity and Frontal alpha asymmetry index (FAA) to determine if there are differences before and after the treatment. EEG FAA is usually calculated by subtracting the right-side EEG power estimates from the respective counterpart on the other side. According to literature, depressive patients seem to have comparatively higher left frontal alpha power. Cortical activity is related to a reduced EEG power, which is reflected in depressed subjects. On the other hand, higher alpha power could also be interpreted as inhibition.
Investigators will try to delineate changes in resting EEG functional connectivity before and after high-frequency left prefrontal rTMS, by using biomarkers such as: time/frequency connectivity, Alpha asymmetry index, among others. TMS also allows cortical properties, such as excitability, inhibition, oscillatory activity and connectivity to be directly probed within a specific region of the cortex. Other studies suggest that alterations in gamma oscillations in the dorsolateral prefrontal cortex and neighboring frontal regions are also potential shared biomarkers in psychiatry, highlighting the potential of EEG signals to help identify suitable biomarkers. Given its relative low cost and ease of use, when compared to brain imaging tools such as magnetic resonance imaging (MRI) or positron emission tomography (PET), EEG could be added to the clinical study so that precise neurophysiological changes before and after treatments can be assessed.
详细描述
rTMS treatment for subjects who are suffering depression and are suitable for rTMS according to the inclusion and exclusion criteria using the FDA MagVenture: MagVita TMS system. This protocol will be conducted following the safety guidelines in order to minimize risk. Dr. Patricia Junquera will be present during the TMS sessions.
For this research study investigators are recruiting patients with depression. Two groups will be created:
Group 1 = Research-onlyGroup; with 2 sub-group: 1-A= TMS treatment up to 6 weeks and 1-B = SHAM 2 weeks + TMS treatment up to 4 weeks.
Group 2 = Treatment + research group, If voluntarily consenting, patients who obtain clinical treatment for depression with TMS at FIU Ambulatory Care Center (ACC) will have EEG, recorded (duration: 20min).
Group 1= Sub-Group 1-A and Sub-Group 1-B Sub-Group 1-A = Research intervention: ten patients will receive active rTMS during 6 weeks (30 sessions). EEG will be recorded before rTMS sessions during session 1, 10, and 30.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Depression
- •must be willing to cooperate.
排除标准
- •implanted electronic devices (e.g., pacemaker, medication pump, brain or vagus nerve stimulator, cochlear implant)
- •history of seizures
- •intracranial metal (e.g., aneurysm clip)
- •inability of the participant to cooperate with the Transcranial Magnetic Stimulation (TMS) session
研究组 & 干预措施
patients with depression
patients with depression
干预措施: MagVita (Device)
结局指标
主要结局
EEG parameters to asses the change
时间窗: Session 1(baseline), Session 10 ( after 2 weeks of treatment), and 30 ( treatment completion)
Resting-state Electroencephalogram (EEG) can serve as an assessment signal that will determine the benefits of the treatment and the efficacy of this procedure. Frequency domain features will be extracted to analyze the change over the time of the treatment. Connectivity maps will be derived for the most important frequency bands( Delta, Theta, Alpha, and Beta).
次要结局
未报告次要终点
研究者
Malek Adjouadi, PhD
Professor
Florida International University