A new clinical trial is investigating the potential of virtual reality (VR)-assisted training to alleviate depression in patients with Parkinson's Disease (PD). The study, conducted at the Neurology Ward of the Union Hospital of Fujian Medical University in China, aims to assess the impact of immersive VR technology on the psychological recovery of individuals diagnosed with idiopathic PD who also exhibit depressive symptoms.
The trial includes participants with PD at Hoehn and Yahr stages 1-3 and Hamilton Rating Scale for Depression (HAM-D) scores between 8 and 20. Key exclusion criteria involve other mental disorders, serious diseases, or poor medication adherence. Participants are randomized into either a VR training group or a non-VR training group receiving treatment as usual (TAU).
VR Training Intervention
The VR training group receives 40 minutes of VR training three times per week for eight weeks, alongside their daily treatment. This VR training utilizes HTC Vive virtual glasses and includes a series of immersive scenes designed to promote relaxation, yoga, task completion, and aerobic exercise. The virtual scenes can be adjusted based on individual preferences.
The non-VR training group receives routine medical and psychiatric treatment without any specific VR intervention.
Outcome Measures and Assessments
Participants are evaluated at baseline, at the end of the intervention, and after 3 and 6 months of follow-up. The primary outcome is measured using the Hamilton Depression Scale-24 (HAM-D24). Secondary outcomes include the 36-Item Short Form Health Survey (SF-36), which assesses functional health and well-being, and measurements of neuroinflammation factors such as Brain-Derived Neurotrophic Factor (BDNF), Interleukin-6 (IL-6), and C-Reactive Protein (CRP).
Functional magnetic resonance imaging (fMRI) is also employed to evaluate changes in brain neural network function before and after the intervention. Researchers hypothesize that VR training, requiring minimal exercise and cardiopulmonary stimulation, may impact spatial memory and navigation, which are closely related to hippocampal and entorhinal network mechanisms.
Sample Size and Recruitment
The study aims to recruit at least 74 participants to account for a 20% dropout rate. This sample size is based on a meta-analysis indicating that VR-based treatments have a significant effect on depressive symptoms, with a reported Hedges’ g of 0.73. Participants are recruited from the outpatient department of the Neurology Department of Union Hospital of Fujian Medical University.