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临床试验/NCT02477722
NCT02477722Unknown不适用

Neurofeedback Preventive Intervention for PTSD: a Method to Strengthen Mental and Emotional Resilience

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Change in Psychiatric Evaluation of PTSD Symptoms

研究概览

简要总结

Exposure to life threatening, traumatic and stress inducing events in general is an inevitable part of military combat service . Among individuals exposed to a traumatic event, approximately 85-90 % will develop a stress response from which they will recover without need for any medical intervention whatsoever. However, roughly 10-15 % will continue to suffer from post-traumatic symptoms along with depression or anxiety disorders1, . The prominent symptoms of post - traumatic stress disorder (PTSD), consists of reliving the event via invasive and painful memories that include: images, thoughts or feelings, night terrors, and extreme emotional distress that arise when exposure to external or internal cues similar to or symbolizing aspects of the traumatic event. Following this distress, behavioral avoidance of situations that trigger unpleasant memories may develop. Such mental stress may lead to avoidance of social situations and hinder normal daily functioning in a variety of contexts2. The question arises as to what distinguishes between those who are exposed to a traumatic event and recover spontaneously and those who fail to resume daily life and develop PTSD. Attempts to find personality and environmental risk factors for the development of PTSD have yet to yield any unequivocal conclusions. This has lead the scientific community to look for neuro-physical risk factors as well . Furthermore, evidence that early diagnosis and treatment of the disorder helps reduce the severity of post-trauma symptoms -stresses the need for the accurate localization of neurological risk factors and new immediate and/or preventative interventions. The aim of the present project is to develop a brain oriented training method for early preventive interventions of PTSD.

详细描述

The most significant disadvantage of the current EEG-NF method is the low spatial resolution of the EEG, which does not allow for the localization of site activity within deep brain regions known to be associated with the development of PTSD, such as the amygdala, the hippocampus, and the mPFC. The aim of the present project is to overcome this drawback by integrating EEG and fMRI imaging methods, such that the patient will receive real-time feedback regarding the activation of emotional target areas located deep within the brain. FMRI is based on the measurement of metabolic changes following electrical activity in the brain, thus non-invasively representing the neuronal activity of various brain regions when performing emotional and/or cognitive tasks. fMRI has high spatial resolution, and in contrast to EEG - it allows for the localization of regions deep within the brain, such as those related to trauma responses within the limbic system and prefrontal cortex. Recently, real-time fMRI (rt fMRI) has been used to train subjects to modulate activity within deep brain regions , . Some studies have even shown that subjects can be trained to regulate activity within a network of regions including the mPFC and limbic regions, resulting in a positive effect on patients suffering from chronic pain and depression . Moreover, it has also been found that via real-time fMRI feedback subjects can be trained to regulate activity within networks that have been linked to emotional regulation; a skill critical for dealing with traumatic events . The major disadvantage of this method is that fMRI tests are expensive and inconvenient for the patient, and the MRI machine required for this method are stationary and not easily accessible.

To combine the advantages of both methods the investigators performed simultaneous testing of both EEG and fMRI. Using special algorithms, with high reliability, the investigators studied the electrical signals that represent activity related to emotional regulation within deep brain regions . This combination allowed for a significant improvement in the spatial resolution of the EEG device and added significant temporal information taken from the fMRI signal. The combined recording of EEG and fMRI with advanced computational methods, such as cross correlation and machine learning, provide significant improvement in the attribution of EEG signal localization, which until now could not be achieved with adequate reliability. In other words, the EEG pattern of activity reliably represents activation of deep limbic regions providing an "electrical fingerprint" (EFP) of these areas.

Accordingly, the investigators developed an innovative treatment protocol in which subjects are asked to control either visual or auditory stimuli, determined by feedback from the brain, based on the extent of the EFP . In a pilot study on a group of civilians the investigators showed that subjects successfully learned to modify their electrical brain signal based on the EFP . In an additional study, simultaneous recordings of EEG and fMRI showed that success was indeed related to changes in activity within deep brain regions involved in emotional regulation; such as the mPFC and hippocampus. Furthermore, our results indicate that following training to volitionally regulate the EFP via EEG-NF, participants exhibited improved emotion regulation .

Rationale for current study:

Based on the EFP model and the NF literature in the treatment of PTSD this study aims to examine the efficiency of an fMRI-guided-EEG-protocol for self-regulation through NF for reducing stress vulnerability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Exposure to traumatic event in the past 14 days. Standard criteria for inclusion in medical MRI scans, according to the procedures set forth at MRI Medical Center in Tel - Aviv Sourasky will be applied to all participants.

排除标准

  • •Standard criteria for exclusion in medical MRI scans, according to the procedures set forth at MRI Medical Center in Tel - Aviv Sourasky will be applied to all participants and in accordance with the "metal form". For example, metal that cannot be removed, Orthodontal accessories connected to ones teeth, or current systemic diseases (including chronic diseases).

研究组 & 干预措施

EFP-NF

Experimental

Subjects are asked to change their brain activity in response to feedback they receive from the brain itself, mediated via various visual or auditory stimuli.

干预措施: EFP-NF (Other)

Sham-NF

Sham Comparator

Placebo

干预措施: Sham (Other)

结局指标

主要结局

Change in Psychiatric Evaluation of PTSD Symptoms

时间窗: Days 1-7 and 6 months after training

次要结局

  • State/Trait Anxiety Inventory (STAI) as a measure of change in state & trait anxiety(Days 1-7 and 6 months after training)
  • fMRI Scan as a measure of change in amygdala reactivity(Days 1-7 and 6 months after training)
  • Debriefing interview questionnaire as a measure of general experience of the process and adverse effects(6 months after training)
  • Change in Emotion Regulation Questionnaire (ERQ) as a measure of change in cognitive coping strategies(Days 1-7 and 6 months after training)
  • Beck Depression Inventory (BDI-II) as a measure of change in clinical depression(Days 1-7 and 6 months after training)
  • PCL as a measure of change in PTSD symptoms(Days 1-7 and 6 months after training)
  • Emotional conflict task as a measure of change in facial recognition measuring emotional regulation(Days 1-7 and 6 months after training)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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