MDS-UPDRS score improvements from baseline were significantly greater in patients using the Personal KinetiGraph.
The Florey Institute and Global Kinetics Corporation (GKC) recently announced data from a clinical trial investigating the FDA-approved Personal KinetiGraph (PKG) that measures and monitors motor symptoms of patients with Parkinson disease (PD).1
Data from the blinded, controlled trial show that there were statistically significant and clinically meaningful improvements Movement Disorder Society-United Parkinson’s Disease Rating Scale’s (MDS-UPDRS) total score, as well as part III and IV scores, in the group using objective measurement with the PKG compared to the conventionally treated group. The PKG treatment arm (PKG+) had a significant improvement of 8.5 points (95% CI, 3.4–14; P = .001) on the UPDRS at the last visit compared to their baseline and improved by 6.3 points (P = .02) more than the group treated with standard care (PKG-).2
Study author Malcolm K. Horne, MBBS, PhD, FRACP, co-founder and executive director, GKC, Florey Institute of Neuroscience and Mental Health, professor of neuroscience, University of Melbourne, commented in a statement “this study provides evidence that objective measurement and targets can improve clinical outcomes for people with Parkinson’s disease. Many clinicians around the world use the PKG to guide their treatment of Parkinson’s. Introducing PKG targets may, in time, enable other clinicians and nurses to treat people with Parkinson’s disease through the lens of objective measurement.”
The study enrolled 200 patients with PD in total, 97 in the PKG+ group and 103 in the PKG- group. Of these patients, 46 withdrew during the study, 7 for protocol violations, 11 referred for device-assisted therapy, and the remaining 28 for other personal reasons. Data from these patients were excluded from analysis.
In the PKG+ group, the MDS-UPDRS total score improved by 8.5 points (14%; 95% CI, 3.4–14, P = .001). MDS-UPDRS III (focused on motor examination) also improved significantly by 6.4 points (18%; 95% CI, 3.6–9.2; P <.001). These changes are of moderate clinical importance. Neither the Parkinson’s Disease Questionnaire 39 (PDQ39; 4.7; 95% CI, −0.2 to 9.5; P = .07) score nor the Severity of predominantly Non-dopaminergic Symptoms in Parkinson’s Disease (SENS PD; 1.2; 95% CI, 0.1–3.6; P = .13) were statistically significant, although the 17% improvement in PDQ39 scores was clinically meaningful.
In the PKG- group, the changes in MDS-UPDRS Total (8%) and 3 (7%) scores, PDQ39 (13%) and SENS (6%) scores were not statistically significant. Patients with the highest MDS-UPDRS III scores at the first visit saw greater improvements at the final visit. In patients in which the first MDS-UPDRS-III score >35 the score differences were of great clinical importance in the PKG+ group but not in the PKG- group.
The PKG+ group improved by 6.3 points more (95% CI, −1.3 to 11.4; P = .02) on MDS-UPDRS total score than the group treated with standard care and by 4.6 points more (95% CI, −1.8 to 7.4; P = .002) on MDS-UPDRS-III score. The 1.5-point difference (95% CI, 1.5–3.0; P = .055) in SENS PD score was not statistically significant and PDQ39 was not significantly different (3.3; 95% CI, 1.8–8.4; P = .21).
Horne and colleagues then calculated the difference between the first and last visit for each arm and then compared these differences between the two groups. The MDS-UPDRS-III difference of 4.1 points was significantly different (95% CI, 1.3–6.9; P = .01) but the 4.4-point difference for MDS-UPDRS total score, while sizable, was not significant (95% CI, 0.6–8.4; P = .07).
“These findings further confirm the need for objective measures of Parkinson’s to more optimally manage symptoms and to evaluate disease and the impact of interventions in research studies,” Mark Frasier, PhD, Senior Vice President of Research Programs, The Michael J. Fox Foundation for Parkinson’s Research (which funded part of the study), stated. “These results could also serve development of an enhanced care model, where continuous symptom monitoring could enable more efficient and tailored treatments.”