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Caloric vestibular stimulation for the management of motor and non-motor symptoms in Parkinson's disease
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3.1 Non-motor symptom (NMS) outcomes
Evaluation of the change in MDS-UPDRS Part I (Non-Motor Aspects of Experiences of Daily Living) from baseline to the end of the treatment period revealed that the active group experienced a significantly greater reduction in the overall burden of NMS relative to the placebo treatment group. Therapeutic gains for this assessment were greatest 5 weeks after the cessation of treatment although change scores at both time-points surpassed a previously established minimal clinically important difference (MCID) [[13]
]. Likewise, active CVS treatment subjects demonstrated significantly greater reductions in NMSS total score than the placebo arm subjects at the end of treatment and which again showed the largest therapeutic gains at the 5-week follow-up assessment. Substantive improvements were demonstrated in most NMSS sub-domains. At the individual subject level, 14 of the 16 active PP subjects demonstrated reductions ≥10 points on one or more domains of the NMSS (Supplemental Fig. 4). Supplemental exploratory post-hoc analysis indicated that there were no interactions with sex, age, time since PD diagnosis, time on anti-Parkinsonian medication, or the VAS score and the observed treatment responses for the NMSS total score. Active arm subjects also demonstrated statistically significant improvements in MoCA scores that persisted through the 5-week follow-up.
3.2 Motor symptoms, ADLs and complications
Active arm subjects demonstrated durable improvements in the MDS-UPDRS Part II (motor aspects of experiences of daily living) and Part III (motor exam) scores that were significantly greater than those for the placebo treatment group, with therapeutic gains exceeding the MCIDs [[13]
,[14]
]. Therapeutic responses were not influenced by sex, age, time since diagnosis, time on anti-Parkinsonian medication, or VAS. Statistically significant differences were also observed in the Modified Schwab & England ADL scale, the 10-m self-paced walk and the Timed-Up-and-Go. Active treatment was also associated with reductions in the MDS-UPDRS Part IV (motor complications) driven primarily by reduced dyskinesias (Supplemental Table 2).