Caloric Vestibular Stimulation for the Management of Motor and Non-MotorSymptoms in Parkinson’s Disease: Intention-to-Treat Data

This report provides data related to the safety and effectiveness of repeated time-varying caloric vestibular stimulation (CVS) as a treatment for motor and non-motor features of Parkinson’s disease (PD). Forty-six subjects receiving stable anti-Parkinsonian therapy were randomized to active (n=23) or placebo (n=23) treatment arms. Subjects self-administered CVS twice-daily over a period of 8 weeks at home via a portable, pre-programmed, solid-state ThermoNeuroModulation (TNM™) device delivering continually-varying thermal waveforms through aluminium ear-probes mounted on a wearable headset. Change scores from baseline to end of treatment and to a 1-month follow-up were determined using standardized clinical measures. The data presented here report sample demographics, detailed safety data and the statistical outcomes from the intention-to-treat and modified intention-to-treat analyses. These data supplement findings of the main per protocol analysis reported in the allied article entitled, ‘Caloric Vestibular Stimulation for the Management of Motor and Non-Motor Symptoms in Parkinson’s Disease’ .