The Effect of Transcranial Magnetic Stimulation to the Frontoparietal Attention Network on Anxiety Potentiated Startle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Anxiety-potentiated Startle
研究概览
简要总结
Background:
Researchers want to better understand brain processes related to fear and anxiety. They want to find out if transcranial magnetic stimulation (TMS), a type of brain stimulation, can reduce anxiety.
Objective:
To see how TMS affects fear and anxiety through memory and attention tasks.
Eligibility:
Healthy people ages 18-50 who are right-handed
Design:
Participants will be screened through another protocol.
Participants in the pilot study will have 1 visit. This includes:
Urine tests
Questionnaires about mood and thinking
Shock and startle workup: Electrodes are taped to the wrists or fingers. Participants will be shocked to find out what level of shock is uncomfortable but tolerable. They will hear loud, sudden noises through headphones.
TMS: A coil is held on the scalp. A magnetic field stimulates the brain. Sometimes they might receive fake TMS. This feels the same as real TMS. They will perform simple tasks. Participants in the main study will have 2 visits within 2 weeks.
The first visit includes:
Urine tests
Questionnaires about mood and thinking
MRI: Participants lie on a table that slides into a scanner. They will be in the scanner about 1 hour. A computer screen in the scanner will tell them to perform simple tasks.
The second visit includes:
Shock and startle workup
TMS
详细描述
Objective: To determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects. Toward this aim we will test the effect of transcranial magnetic stimulation (TMS) on two outcome measures: 1) Fear and anxiety during the threat of predictable and unpredictable shock (NPU threat test; Substudies 1 and 3), and 2) Working memory (WM) related anxiety downregulation while performing the Sternberg WM task under threat of shock (Substudy 2).
Study population: The study population will consist of up to 184 healthy volunteers between the ages of 18-50.
Design: This study will consists of two (sub-studies 1 and 2) or three (sub-study 3) outpatient visits (1 MRI, 1 or 2 TMS visits [2 for sub-study 3]). In this protocol we will explore the effect of TMS in three sub-studies in the TMS study visit. The sub-studies will contain either the NPU or the Sternberg task during the TMS visits. The first visit (MRI) will consist of the same procedures for all sub-studies. Each subject will be assigned to only one of the sub-studies.
Sternberg Task: Expose subjects to active or sham TMS to a region of the frontoparietal attention network during the Sternberg WM task. Subjects will have to maintain a series of letters in WM for a brief interval during blocks of safety and threat of shock.
NPU Task: Expose subjects to active or sham TMS to a region of the frontoparietal attention network during the NPU threat test. Subjects will be exposed to blocks in which they are either 1) safe from shock (neutral), 2) at risk of shock delivered only during a cue (predictable), or 3) at risk of shock presented randomly (unpredictable).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
研究组 & 干预措施
Substudy 1 Active and Sham
HVs that receive TMS over the right dlPFC
干预措施: Transcranial Magnetic Stimulation Sham (Drug)
Substudy 1 Active and Sham
HVs that receive TMS over the right dlPFC
干预措施: Transcranial Magnetic Stimulation (Device)
Substudy 2 Active and Sham
HVs that receive TMS over the right dlFPC
干预措施: Transcranial Magnetic Stimulation Sham (Drug)
Substudy 2 Active and Sham
HVs that receive TMS over the right dlFPC
干预措施: Transcranial Magnetic Stimulation (Device)
Substudy 3 Active and Sham
HVs will receive offline TMS to the lest IPS (FPN)
干预措施: Transcranial Magnetic Stimulation Sham (Drug)
Substudy 3 Active and Sham
HVs will receive offline TMS to the lest IPS (FPN)
干预措施: Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Anxiety-potentiated Startle
时间窗: Pre and post stimulation
Electromyography Facial electromyography (EMG) startle responses were recorded from the left orbicularis oculi muscle at 2000 Hz using a Biopac MP160 unit (Biopac; Goleta, CA) via 15 × 20 mm hydrogel coated vinyl electrodes (Rhythmlink #DECUS10026; Columbia, SC). Startle 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, we subtracted the response during the neutral ITI from the response during the unpredictable ITI.
Working Memory (WM) Related Anxiety Downregulation While Performing the Sternberg WM Task Under Threat of Shock.
时间窗: Pre and post stimulation
Sternberg Task: Expose subjects to active or sham TMS to a region of the frontoparietal attention network during the Sternberg WM task. Subjects will have to maintain a series of letters in WM for a brief interval during blocks of safety and threat of shock. Electromyography Facial electromyography (EMG) startle responses are recorded from the left orbicularis oculi muscle at 2000 Hz. Startle EMG is bandpass filtered from 30 to 300 Hz, rectified, and smoothed using a 20-ms sliding window. Startle responses are 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 (tx = \[Zx × 10\] + 50). Noisy trials (baseline SD \> 2x run SD) are excluded, and "no blink" (peak \< baseline range) trials are coded as 0. These t scores are then averaged across trials within each condition, and threat-safe contrasts are calculated independently for each level of load (low vs. high) and timing (maintenance vs. ITI).
次要结局
未报告次要终点