Open-label Pilot to Test a Novel 1 Hz Intensive Repetitive Transcranial Magnetic Stimulation Paradigm in Patients With Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Anxiety Potentiated Startle (APS)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of 1 Hz parietal stimulation in anxiety. Our approach will be to administer 1 week of open-label accelerated 1 Hz parietal rTMS (5 days, 8 sessions/day, 600 pulses/session) and measure the effect of this neuromodulation on APS, and short term memory in a cohort of anxiety GAD patients.
详细描述
Aims 1 and 2 of this project will be tested using a within-subjects design where anxiety patients will receive a 5-day course of accelerated 1 Hz rTMS (8x session x 600 pulses/session) to the right IPS. In Aim 1, we will test the effects of this stimulation on arousal during the NPU threat task (NPU section). In Aim 2 below, we will test the effects of this stimulation on arousal-related attention control deficits using the VSTM task (VSTM section).
Subjects will undergo 7 study visits spaced over a roughly 3-week period depending upon availability. First, subjects will have a pre-stimulation test visit. On this visit they will undergo the following procedures: 1) motor threshold testing, 2) noise habituation, 3) shock workup 4) NPU task, 5) VSTM task. Then they will have 5 rTMS visits. On these visits, subjects will receive 8 trains of 1 Hz rTMS (600 pulses per train, each separated by ~50 min). Finally, they will have a post-stimulation test visit, which will included the noise habituation, shock workup, NPU task, and VSTM task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Anxiety Potentiated Startle (APS)
时间窗: Post stimulation
Electromyography (EMG) startle responses were recorded from the left orbicularis oculi muscle using a Biopac MP160 unit (Biopac; Goleta, CA) via 15 × 20 mm electrodes (Rhythmlink #DECUS10026; Columbia, SC). EMG was bandpass filtered from 30 to 300 Hz, rectified, and smoothed using a 20-ms sliding window. Startle responses were scored as the peak (max during the 20 ms to 120 ms post-noise window) - the baseline (50 ms pre-noise window), and converted to t-scores with a mean of 50 and a standard deviation of 10 (tx = \[Zx × 10\] + 50). Greater t-scores mean larger blinks, which could be associated with greater anxiety, however there is no clinically relevent threshold. Noisy trials (baseline SD \> 2x run SD) were excluded, and "no blink" (peak \< baseline range) trials were coded as 0. To calculate APS within each timepoint, we subtracted the response during the neutral ITI from the response during the unpredictable ITI. T-scores represent the change from baseline to post stimulation.
Visual Short Term Memory Performance (VSTM)
时间窗: Pre and post stimulation
Visual short term memory task: This task has been adapted from Vogel \& Machizawa (Vogel \& Machizawa, 2004). On each trial, subjects see an arrow (cue) pointing to the left or the right. After a short delay, they see a bilateral array of squares that vary in color, location, and angle of rotation (memory array). Subjects are instructed to encode the squares in the cued hemifield (targets) and ignore the squares contralateral to the cued hemifield (distractors). After another short delay (retention interval), subjects see a single square (response prompt) that is either an exact match (same color/location/angle) or a complete mismatch (different color/location/angle). Subjects are instructed to indicate whether the square is a match or a mismatch.
次要结局
未报告次要终点