Caloric vestibular stimulation (CVS) stimulates the vestibular system, a sensory network with diffuse pathways throughout the brain. The vestibular system is responsible for providing the brain with information about motion, head position, and spatial orientation.
Previous investigation has shown that eight weeks of twice-daily treatment using the proposed non-invasive time-varying caloric vestibular stimulation device at home was associated with significant reductions in motor and non-motor symptoms in patients with Parkinson’s disease. Study participants reported treatment was highly tolerable and the device was easy to use. The device uses aluminum earpieces in a headset (similar to headphones) to activate the vestibular system. Device treatments have been shown to strongly regulate blood flow dynamics in the brain. Owing to its widespread connectivity, the vestibular system is an ideal conduit for non-invasive brain stimulation.
This study tests the hypothesis that time-varying caloric vestibular stimulation improves symptoms associated with Parkinson’s disease by modulating brain function.
Participants will be trained to use the device and will self-administer treatments (either active or placebo) at home twice daily for 12 weeks. We will monitor effects on brain functional connectivity and blood flow using functional magnetic resonance imaging (fMRI), and we will assess symptoms using standardized clinical scales. We will evaluate effects of the treatment by comparing the change in scores from the pre-treatment baseline to the post-treatment assessment between the active and placebo treatment groups. We will compare changes in brain function and symptoms to evaluate potential causal relationships.
Impact on Diagnosis/Treatment of Parkinson’s disease:
These results will help guide modifications to the time-varying caloric vestibular stimulation device that may allow for greater reductions in Parkinson’s disease-related symptoms. This study will also add to the body of work required for insurance companies to cover a new treatment.
Next Steps for Development:
If successful, the outcomes will be used to guide future investigations, including (1) a study design to identify biomarkers during treatment that will enable individualized treatment protocols for maximum clinical effectiveness, (2) a larger multi-center clinical trial to confirm the mechanism(s) of action for this treatment, and (3) to guide a future pivotal trial investigating the safety and efficacy of treatments stemming from this work.