Dr Carrolee BarlowCarrolee Barlow, MD, PhD
New study results have shown that the Personal KinetiGraph (PKG), is able to provide novel additional information about patients with Parkinson disease beyond what is regularly captured in routine clinic visits.1

The PKG, a wearable monitoring device which detects, quantifies, and reports movement disorder symptoms in these patients, provided information significant enough to result in a change in the medical management of almost one-third of patients in the study. Ultimately, 41% (n = 46) of physicians surveyed indicated that the device provided relevant additional information considered sufficient enough to consider a therapeutic management plan adjustment.2

The device was developed by Global Kinetics in conjunction with the Florey Institute of Neuroscience and Mental Health in Melbourne, Australia. The joint study was conducted by Global Kinetics and the Parkinson’s Institute and Clinical Center.

“The Parkinson’s Institute and Clinical Center is at the forefront of evaluating new technologies and therapeutics and is committed to providing the highest quality of care for people with movement disorders,” Carrolee Barlow, MD, PhD, the former chief executive officer of the Parkinson’s Institute and Clinical Center and an author on the study, said in a statement. “The wearable PKG technology provides objective measurements which allow us to further deliver the highly individualized care that a patient deserves.”

The study sought to evaluate the impact of using continuous, object measurement using the PKG movement recording system in comparison with routine clinical care in patients with Parkinson. In order to do so, the investigators gave physicians PKGs to use, and they were administered for patients to wear for ≥6 days during routine daily living activities from December 2015 to July 2016. Physicians selected patients which they believed the device would improve the value of clinical encounters for, which included those who were on a first-time visit, who had symptom fluctuations related to therapy, who had an indeterminate history, and who were considering or using deep brain stimulation or carbidopa/levodopa enteral suspension (Duopa, AbbVie).

"Neurologists currently provide personalized dosing and therapy decisions based on self-reported (or caregiver-reported) symptoms and subjective observation of the patient during the limited window of an in-office consultation," Fatta Nahab, MD, an associate professor of Neuroscience at UC San Diego, told NeurologyLive. "This may lead to sub-optimal dosing due to fluctuating symptoms and inability of patients and their care partners to accurately assess symptoms over an extended period, particularly relative to the timing of medication doses. The availability of a continuous objective measurement of Parkinson’s movement symptoms aims to enhance therapy optimization—the PKG is the first FDA-cleared technology to provide continuous quantitative data on movement disorder symptoms including tremor, bradykinesia and dyskinesia in a non-clinical setting. The wearable technology is worn at home by patients for several days to help objectively monitor motor symptoms and the information is then interpreted and  transmitted to their physician for review during their next clinical visit."

In total, 143 PKGs were ordered for 89 patients, with 44 of those patients being administered 2, and 10 being administered 3. On the physician side, 119 of 143 surveys were completed, 112 of which were included in final analysis (completion rate, 83%). Of the 46 surveys which indicated that the PKG provided additional patient information, 36 (78%) stated that said information resulted in an alteration in patient care. Overall, 32% of the full cohort reported that the monitoring device resulted in an adjustment to care.

Data from the 36 patients for whom care was modified based on the PKG showed that the device yielded new and precise information on daily off time for 50% (n = 18) of patients. The subgroup of patients who showed Parkinson disease symptom fluctuation had the largest proportion of surveys completed in the modified treatment group (21 of 36), followed by the first-visit group (8 of 36).

Barlow and investigators wrote that this “project reflects real-life in that it includes typically-encountered PD patients along the continuum of disease, and physicians with varying levels of clinical experience with continuous objective measurement,” adding that this type of monitoring provided by the PKG “has the potential to add value in non-specialty care centers as well, where a substantial portion of the [Parkinson] patient population receives care and providers generally see a smaller overall percentage of PD patients within their population.” They concluded that it could provide even greater support to physicians and patients for symptom identification, patient counseling, and treatment planning.

Notably, the investigators wrote that while this study found patient engagement in the use of wearable devices to be positive, the management of Parkinson is highly individualized and determined by physician-patient interaction, prompting the group to suggest that future research should incorporate patient perspectives.

“These results demonstrate the real-world clinical benefits that PKG can provide to patients and clinicians in their continuing effort to optimize [Parkinson] therapy, and manage symptoms effectively,” John Schellhorn, CEO of Global Kinetics Corporation said. “In the absence of standardized objective measures for assessing and managing [Parkinson], we believe that PKG has the potential to transform the care and outcomes of patients living with the daily challenges of this disease. The results of this study support the use of PKG as an important tool for individualizing therapy to best meet each patient’s unique needs.” 
REFERENCES
1. Data Published in the Journal of Parkinson’s Disease Demonstrate Real-World Clinical Benefit of Global Kinetics’ Personal KinetiGraph® in Optimizing Parkinson’s Disease Therapy [press release]. Portsmouth, NH; London, UK; Melbourne, Australia: Global Kinetics Corporation
2. Santiago A, Langston JW, Rita G, et al. Qualitative evaluation of the Personal KinetiGraph movement recording system in a Parkinson’s clinic. J Parkinson Dis. Published pre-press November 8, 2018. content.iospress.com/articles/journal-of-parkinsons-disease/jpd181373. Accessed February 4, 2019.