A Multisite Randomized Clinical Trial to Examine the Efficacy and Mechanisms of Immersive Virtual Walking Treatment for Neuropathic Pain in Spinal Cord Injury
Abstract
What is the purpose of this clinical trial? Chronic neuropathic pain (NP) can be debilitating for persons with SCI and does not respond to available treatments. We will test a promising new treatment – immersive interactive virtual reality walking – for SCI NP. Our interactive VR platform (VRWalk) allows persons with SCI NP to walk through virtual worlds by controlling movement of virtual legs. This builds on “mirror” therapies for phantom limb pain, which provide amputees with a visual representation of their missing limb. These therapies are understood to work by affecting maladaptive brain changes that accompany NP. Why did we decide to pursue this project? There is urgent need to advance promising treatments for SCI NP. Evidence from our group and others suggests that “illusory walking” offers SCI NP relief. Our interactive VR platform is a major advancement; to date, illusory walking treatments allowed only passive viewing of a video of walking legs. Many studies now show that the volitional and interactive properties of our VR platform are critical to ameliorating NP. Promising preliminary findings support our confidence in this intervention. We will also improve on previous studies by adding brain imaging to better understand how to treat SCI NP. This is vital to have a meaningful impact on science and the lives of those with SCI NP. What will the clinical trial look like? The trial will compare effectiveness of our interactive VRWalk treatment against existing passive illusory walking treatment. The study will be conducted at research sites in the US and Australia to combine expertise and allow large-scale recruitment. At both sites, individuals with complete paraplegia and SCI NP will be randomized to the interactive VRWalk Treatment condition or a passive viewing Control condition – this will be identical to the VRWalk condition but will not allow participants to control their virtual legs. Participants in both conditions will receive 20 sessions of the 5-10 minute intervention within their home environment. SCI NP intensity measures will be collected prior to and immediately following treatment, as well as at 3, 6, and 12 months after treatment completion. Brain imaging measures will be collected prior to and immediately following treatment and at 6 months after treatment. Follow-up measures let us see duration of potential treatment effects. To reduce bias, assessment staff will not be aware of participant group assignment and participants will not know if they were assigned to the group we expect to be more effective. We will then statically test our hypothesis that participation in the VRWalk Treatment condition will have greater reduction in SCI NP intensity and greater adaptive changes in the brain. What is the ultimate applicability of the future clinical study? The intervention is expected to have short and long-term application within clinical care settings across early and late stages of treatment, as well as various kinds of SCI injury. Findings will also inform research regarding other possible applications of this platform. In addition, the knowledge gained from neuroimaging can help shape alternate treatments for SCI NP. What persons with SCI will it help, and how will it help them? We aim to provide a readily-accessible treatment for individuals with SCI NP. The proposed study will test the intervention among individuals with lower limb paralysis. If effective, the intervention will be extended to additional levels of SCI and motor function. What are the potential clinical applications, benefits, and risks? The VR Walking intervention may provide one of the only accessible nonpharmacological treatments for an otherwise refractory condition, and is readily adaptable for clinic/rehabilitation or self-guided home use. There is a risk that some individuals may experience nausea negative emotional reactions to the virtual images; however, this was not observed in pilot testing. What
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010775
Entities
People
- Zina Trost
Organizations
- United States Army
- Virginia Commonwealth University