Improving Dysregulated Neural Networks With EEG-neurofeedback - A Randomized Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Pain intensity rating
研究概览
简要总结
Comorbid PTSD in the context of chronic pain rehabilitation is a major problem. The lack of effective and efficient methods that can be integrated into current practice is needed. The current recommended treatments for PTSD leave room for supplementary approaches to achieve symptom reduction. PTSD is characterized by specific alterations of neural activity, and the DMN is known to be involved in this. Neurofeedback is the most current approach to altering neural activity patterns towards a norm pattern found in healthy subjects.
The aim of the present study is to assess whether EEG neurofeedback compared to an active control group receiving EEG sham neurofeedback is effective in alleviating PTSD symptoms and pain intensity in patients with chronic pain and comorbid PTSD after MVCs.
详细描述
Prevalence and current treatment of PTSD PTSD is a debilitating mental health disorder arising from exposure to traumatic events such as war, motor vehicle accidents, crimes, and other events, threatening the lives of oneself or others involved (American Psychiatric Association, 2013).
The current recommended treatments for PTSD victims consist of psychotherapies and pharmacological interventions (NICE, 2005). Although 60% of PTSD patients experience improvements from a variety of trauma-focused cognitive behavior therapies (Bradley et al., 2005), and pharmacotherapies (Ipser et al., 2006), as many as 40% of PTSD patients do not experience symptom relief from existent therapies. Thus, the development of novel treatment alternatives is needed.
Injuries related to motor vehicle crashes (MVC) are one of the major causes of morbidity and mortality in the Western world (Peden et al., 2004). While physical injury and pain are the primary symptoms after MVC, between 20-40% also experience severe posttraumatic stress disorder symptoms (Craig et al., 2016). What is less known is that psychological distress is higher among those who have sustained a minor injury, such as whiplash injury, compared to more severe injuries, such as spinal cord injury. In particular PTSD symptoms such as hyperarousal are common after MVCs and an important mechanism in the development of chronic pain and disability after MVCs (Buitenhuis et al., 2006; Sterling et al., 2012; Ravn et al., 2018). With the mutual maintenance theory (Sharp & Harvey, 2001), it is suggested that pain and PTSD are mutually maintaining conditions. Indeed, PTSD is highly prevalent in the context of chronic pain rehabilitation of victims of MVCs with about 20% experiencing severe PTSD symptoms (Siqveland et al., 2017). Those with high levels of PTSD symptoms are known to experience higher levels of pain, disability, and distress. Unfortunately, targeting PTSD in pain rehabilitation is uncommon and the few existing trials that have tried to target comorbid PTSD and pain have not been sufficiently effective in alleviating pain and PTSD symptoms (Andersen et al., 2017; Andersen et al., 2020; Andersen et al., 2021). Treatment resistance may be due to dysregulated brain networks that are not sufficiently targeted with traditional psychotherapeutic approaches.
A novel and promising method to target PTSD is source-localized EEG neurofeedback in that this method targets specific neural regions; thus, the treatment can be tailored to the individual patient's symptoms. As the treatment is entirely noninvasive and low-cost, the potential and the feasibility that the neurofeedback method can be employed broadly and that patients can train in between treatment sessions is considerable.
Here, we propose an investigation of the potential of standardized weighted Low-Resolution Tomography EEG neurofeedback training in treatment of comorbid PTSD in chronic pain. Our proposed study investigates the neural mechanisms hypothesized to be involved in neurofeedback training for PTSD patients. By testing, if such training can alter activity in specific target neural regions related to PTSD symptoms in our patient group, the goal is to evaluate the technique as a supplement to current therapies. We compare the active EEG neurofeedback treatment with a placebo control condition receiving sham EEG neurofeedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has finished treatment at Smertecenter Syd.
- •is still experiencing pain of more than 4 on the Numeric Ranking Scale (NRS).
- •has been exposed to an adverse event that causes continued arousal according to the International Trauma Questionnaire.
排除标准
- •Participants with known neurological disorders will be excluded from participation.
结局指标
主要结局
Pain intensity rating
时间窗: Before every nf-session and six months after the last session.
Average pain intensity during the last day and current pain intensity before beginning the neurofeedback session, will be assessed on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain)
EEG-power in alpha band
时间窗: Before the first nf-session and after the last session (roughly six weeks later)
37-channel EEG will be recorded, the alpha power seems to indicate cortical activity.
次要结局
- General QoL(Assessed before first nf-session, after five weeks and after seven months.)
