A Virtual World/Neurofeedback Real Time Functional MRI Approach to PTSD Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- CAPS-5 PTSD Criteria
研究概览
简要总结
A commonly used therapy for post-traumatic stress disorder (PTSD) that often (but not always) gives good results is "exposure therapy": When the patient (for example, Veterans who have attacks of anxiety when a noise startles them) talks about the trauma that precipitated the PTSD, she or he slowly becomes less sensitive to PTSD. This works only on some patients. The investigators propose to expose PTSD patients to a number of "training" sessions in which they will be in a virtual world (similar to a video game) driving a car through a place resembling Iraq. This will happen inside an MRI machine, and the investigators will obtain brain images while the patient is exploring the "virtual Iraq" environment. The investigators will project on the screen a bar that will let the patient know, in real time, which is the state of her or his brain, from CALM to STRESS. The job of the patient will be to try to come up with personal strategies (breathe slowly, think calming thoughts) to try to bring the bar to CALM. The investigators believe that after a number of sessions, the patient will be able to create personalized mental strategies to bring their brain to CALM state, even in real life. This could become a much stronger way of performing "exposure therapy". Finally, the investigators will use a wearable device (similar to a wristwatch) to be able to study physical activity and sleep patters in PTSD patients through the training, in the hope that the investigators may find a way to objectively study when a patient is doing better.
详细描述
A Virtual World/Neuro-feedback Real-time Functional MRI Approach to PTSD Treatment
Despite availability of treatment, posttraumatic stress disorder (PTSD) remains a major problem in Veterans, with tremendous impact on patients, their families, and the VHA system. A major therapeutic approach used for Veterans with PTSD is exposure therapy, with beneficial effects in many patients. However, improvements on current therapies are needed.
The overarching hypotheses of this proposal are two-fold. First, that brain activity measured with functional MRI (fMRI) can be used to discern the different brain states of a PTSD patient during a threatening experience vs. during a calm moment, and that patients, aided by neuro-feedback derived from real-time fMRI during a virtual reality experience, can learn to reduce their response by willfully modifying their brain state. Secondly, that the continuous measurement of physical activity, heart rate, and sleep patterns using wearable devices can help in the study of PTSD treatment trajectories.
Investigators will combine virtual worlds, machine learning, real-time fMRI, and neuro-feedback to provide a novel PTSD treatment that the investigators hope will be more effective than current alternatives, at least in certain challenging cases. The investigators will construct a computational model specific for patient+stimulus combination. This is critical as PTSD patients are very heterogeneous.
Aim 1. Use of Virtual World/Neurofeedback with Real-Time fMRI as therapy for PTSD Fifteen PTSD patients recruited at MEDVAMC will be exposed to Virtual Iraq, a virtual world platform in which they will be exposed to war-like scenarios, and to calm scenes where no threat will be present. Brain activity will be collected using fMRI and analyzed with machine learning to discern between both extreme brain states (STRESS vs. CALM). These two states will be used during neurofeedback training: In the following weeks, participants will be exposed to 7 fMRI/Virtual World sessions in which they will be instructed to try to move a gauge to the CALM side by using individual mental strategies (active like concentrating on a particular memory, or passive as it has been shown that neurofeedback does not necessarily need willful effort to work). The stressfulness of the Virtual World will be manipulated by the gauge: when the patient is able to move the bar toward CALM (by bringing the brain toward that state) the stressfulness of the Virtual World will decrease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet CAPS5 PTSD criteria
- •OEF/OIF/OND & PGW Veterans
- •Seeking treatment for PTSD
排除标准
- •DSM-5 criteria for drug or alcohol abuse or dependence in past 30 days
- •History of moderate to severe traumatic brain injury
- •Presence of contraindications to MRI
- •Current neurological or general medical conditions known to impact cognitive and/or emotional functioning (epilepsy, Parkinson's, etc.)
- •Acute psychological instability, schizophrenia, etc.
结局指标
主要结局
CAPS-5 PTSD Criteria
时间窗: 6 weeks
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview that can be used to determine: current (past month) diagnosis of PTSD, lifetime diagnosis of PTSD, PTSD symptoms over the past week. Scores range from 0 - 80, with higher scores indicating increased PTSD symptom severity. The full interview takes 45-60 minutes to administer. In addition to PTSD symptoms, questions target symptom onset and duration, subjective distress, impact of symptoms on social and occupational functioning, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The CAPS-5 produces reliable and valid scores with standard administration. It should be administered by qualified interviewers with formal training in structured clinical interviewing and differential diagnosis, a thorough understanding of the conceptual basis of PTSD, and detailed knowledge of the measure's features and conventions.
次要结局
- Wearable Device Data: Heart Rate(Change from baseline at 6 weeks)
- Wearable Device Data: Sleep Patterns(Change from baseline at 6 weeks)
- Wearable Device Data: Total Sleep(Change from baseline at 6 weeks)