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临床试验/NCT04325087
NCT04325087Unknown不适用

Reduction of Trauma-induced Intrusions and Amygdala Hyperreactivity Via Non-invasive Brain Stimulation

University Hospital, Bonn2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
Number and quality of intrusive thoughts

研究概览

简要总结

The study will focus on the modulation of intrusive memories via functional magnetic resonance imaging (fMRI)-guided repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex (dlPFC) directly after exposure to a traumatic video.

详细描述

Traumatic experiences can lead to posttraumatic stress disorder (PTSD) with clinical manifestations including intrusions, avoidance behavior, and hyperarousal. Unlike most other psychological disorders, a PTSD diagnosis requires a clearly identifiable inciting event. As such, preventive interventions in recently traumatized individuals seem promising.

In this randomized, placebo-controlled study the investigators explore the potential of individualized transcranial magnetic stimulation (TMS) to reduce trauma-induced intrusive thoughts by altering functional connectivity between the dorsolateral prefrontal cortex (dlPFC) and amygdala. Subjects will undergo a functional magnetic resonance imaging (fMRI) session consisting of a resting state scan, an emotion recognition task and an anatomical scan at the beginning of the study (day 1). Resting state data will be used to determine individualized TMS targets for every subject, depending on functional connectivity between the dlPFC and amygdala. Subsequently, the analogue trauma model will be used to induce intrusions in healthy subjects. Subjects will be confronted with a video clip from the movie "Irreversible" and they will complete online questionnaires in the following three days to measure intrusive thoughts, trauma disclosure (i.e. duration of conversations about the aversive movie) and sleeping quality. Intermittent theta-burst stimulation (iTBS) will be administered directly after the video clip and on the following two days (day 2-4). Cognitive tasks will be applied before and after iTBS sessions to examine short-term effects of iTBS on a behavioral level. Finally, subjects will undergo a second fMRI session similar to the first one, to probe iTBS-induced changes in functional connectivity and emotional processing (day 5).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects

排除标准

  • current psychiatric illness
  • current psychiatric medication or psychotherapy
  • past PTSD diagnosis
  • MRI contraindication (e.g. metal in body, claustrophobia)
  • pregnancy

结局指标

主要结局

Number and quality of intrusive thoughts

时间窗: Three days after trauma exposure

Sum and stress ratings of intrusive thoughts measured on three consecutive days after trauma exposure by an online questionnaire.

Changes in resting state functional connectivity

时间窗: 10-minutes resting state fMRI scans before and after three sessions of TMS treatment

Functional connectivity data will be assessed by two 10-minutes resting state fMRI scans before and after three sessions of TMS treatment over the course of three days. The resting state fMRI analysis will focus on changes in functional connectivity between regions-of-interest (ROIs) associated with intrusive memories (prefrontal cortex, amygdala, precuneus, insula, hippocampus, cingulate cortex). Changes in functional connectivity between the first and second fMRI sessions will be computed on the first level and independent t-tests will be used to compare the verum and sham TMS groups.

Changes in neural response to an emotion recognition task

时间窗: 15-minutes emotional face matching fMRI task before and after three sessions of TMS treatment

Changes between the first and second fMRI session in the blood-oxygen-level-dependent (BOLD) signal in response to happy, fearful and neutral faces as well as houses will be compared between the experimental groups. Analysis will focus on anatomically defined regions-of-interest (ROI) associated with emotion processing (i.e. amygdala, prefrontal cortex, insula, striatal areas). Changes in the neural response and functional connectivity between the first and second fMRI sessions will be computed on the first level and independent t-tests will be used to compare the verum and sham TMS groups. For analyses of fMRI data, standard procedures of the software SPM12 will be used.

次要结局

  • Changes in electrodermal responses to the trauma video(5 minutes before and during the trauma video)
  • Respiratory changes in response to the trauma video(5 minutes before and during the trauma video)
  • Heart rate changes in response to the trauma video(5 minutes before and during the trauma video)
  • Food craving task(Before and three days after trauma exposure)
  • Childhood maltreatment(Before first fMRI scan)
  • Delayed discounting task(Before and three days after trauma exposure)
  • Changes in positive and and negative affect in response to the trauma video(10 minutes before and 10 minutes after trauma exposure)
  • Changes in executive functioning (One Touch Stockings of Cambridge) and attention (Rapid Visual Information Processing) during iTBS treatment(15-minutes cognitive tasks pre/post first iTBS and pre/post last iTBS treatment)
  • Trauma disclosure(Three days after trauma exposure)
  • Changes in anxiety in response to the trauma video(10 minutes before and 10 minutes after trauma exposure)
  • Dissociative symptoms after trauma exposure(10 minutes after trauma exposure)
  • Sleep quality: visual analog scales(Three days after trauma exposure)

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rene Hurlemann

Professor Rene Hurlemann, M.Sc., M.D., Ph.D.

University Hospital, Bonn

研究点 (2)

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