Tracking patients’ progress is a critical part of managing multiple sclerosis (MS), a dreaded inflammatory disease of the central nervous system (CNS) that too frequently afflicts people beginning in young adulthood, particularly women.
As the disease progresses, inflammation flakes can occur unpredictably and intermittently in optic nerves, brain, and spinal cord. Episodic symptoms, termed “relapses,” characterize the early relapsing remitting stage of MS (RRMS), during which irreversible CNS tissue injury accumulates, manifesting as progressive brain atrophy and eventually neurological disability, which is generally delayed for typically for 10-20 years after MS symptom onset.
During more advanced stages of MS, termed secondary progressive MS (SPMS), relapses occur less frequently or disappear entirely, but gradually worsening neurological disability ensues, and patients experience some combination of difficulty with walking, arm function, vision, or cognition—a process that can benefit from greater objective analysis.
Researchers at the Cleveland Clinic in Cleveland, Ohio, have determined that Apple’s iPad (and potentially other tablet computers that feature built-in technologies like accelerometers, gyroscopes, and touchscreens), when combined with appropriate software, can provide pretty good MS assessment capabilities.
The Cleveland Clinic research team reports how they’re using the iPad as a tool to perform an array of performance tests relevant to MS assessment in an Open Access study published in the Journal of Visualized Experiments (JoVE). For example, they explain that by attaching the iPad to a patient’s back while having her walk and balance, the app running provides precise data on posture.
In another evaluation protocol, a specially built attachment that sits on the top of the iPad’s screen allows for dexterity testing using metal pegs. The patient moves pegs between different holes as requested by a therapist, and the iPad software tracks the timing of the pegs being moved, translating that into an objective evaluation of the subject’s manual dexterity.
The iPad model used in this study was Apple’s current entry-level full-size iPad with Retina Display (16 GB, Wi-Fi, White – 4th generation (MD513LL/A)).
An ocular test that analyzes low contrast vision is also included in the testing work up, along with a simple cognitive processing test to provide insight on how well the brain is functioning.
In the JOVE paper, entitled “The Multiple Sclerosis Performance Test (MSPT): An iPad-Based Disability Assessment Tool?” (6/30/2014, Issue 88; doi: 10.3791/51318), the research team documents high precision, strong correlations between MSPT component test results and the analogous technician-based testing, favorable sensitivity in distinguishing MS from controls and mild from severe MS, as well as significant correlation between patient reports and MSPT testing of walking and hand function. In all comparisons, MSPT testing compares favourably to conventional technician-based testing, and the iPad based testing has been received with high test subject acceptance.
The study report’s coauthors note that precise measurement of neurological and neuropsychological impairment and disability in multiple sclerosis is challenging for a variety of reasons. First, clinical manifestations vary widely in different MS patients. Second, disease activity varies significantly over time in individual MS patients. Third, MS symptom and impairment manifestations vary in early compared with late disease stages. Lastly, neurological and neuropsychological impairment and disability are inherently difficult to quantify.
They report that the new test they’ve developed—dubbed “the Multiple Sclerosis Performance Test” (MSPT)—represents a new approach to quantifying MS related disability. The MSPT takes advantage of advances in computer technology, information technology, biomechanics, and clinical measurement science, and represents a computer-based platform to provide a more precise, valid measurement of MS severity.
The researchers observe that conducting neurological performance testing within the computer environment enables various direct manipulations and analyses of primary and derivative data. Moreover, results can be directly transmitted to research or clinical data repositories without paper or electronic case report forms, substantially reducing the need for manual data quality checks, the cost of transcribing data manually, and with reduced potential for human error—advantages that should translate to improved efficiency and data quality.
Reproducibility was tested for all measures by having each research subject perform each test twice, both during a morning test session and during a second test session in the afternoon following a 2 to 4 hour rest period. Test-retest reproducibility was analyzed by inspecting visual plots, and by generating concordance correlation coefficients. Concurrent validity was tested by comparing the technician and iPad based testing for each of the four dimensions using Pearson Correlation Coefficients.
Based on—but extending the Multiple Sclerosis Functional Composite (MSFC)—the MSPT provides precise, quantitative data on walking speed, balance, manual dexterity, visual function, and cognitive processing speed, discriminated MS from HC and severe from mild MS, and correlated with patient reported outcomes.
A demonstration video explaining use of the iPad can be accessed from the study site.
The researchers believe MSPT is a potentially transformative approach for collecting MS disability outcome data for patient care and research. Because the testing is computer-based, test performance can be analyzed in traditional or novel ways and data can be directly entered into research or clinical databases. The MSPT could therefore be disseminated to clinicians who practice in settings not connected to clinical trial performance sites—in rural settings, for example—drastically improving access to clinical trials for clinicians and patients.
Patients could be tested using the MSPT in rural doctor’s offices, potentially enabling participation in clinical trials for patients who might otherwise be unable to simply because of distance. The MSPT could also be adapted to out-of-clinic settings, like the patient’s home, thereby providing more meaningful real world data. The MSPT could moreover be used in practice settings (e.g., MS clinics) to collect standardized neuroperformance information. Because the data is standardized and quantitative, MSPT could provide a highly cost-efficient mechanism to collect MS assessment data during routine clinical practice. This could populate research registries and inform practice-based research related to natural history, treatment, effects of co-morbidities, and various other important topics.
The researchers say it’s important to note that the iPad is used as a platform to host the data collection and processing algorithms in the software. Much like other computerized testing approaches, the software is written in such a manner that, should Apple or other tablet makers update the hardware or operating system, adjustments can be made in the acquisition and processing of the data to ensure that outcomes remain consistent across test modules and do not have to be re-validated under the future device or software configurations.
The Cleveland Clinic team affirms that with neuroperformance testing increasingly applied in MS and other chronic neurological and neuropsychological disorders, MSPT represents a new paradigm for neuroperformance testing that could have the same transformative effect on clinical care and research in MS as standardized computer-adapted testing has had in the education field, with clear potential to accelerate progress in clinical care and research.
For more information, see the Open Access JOVE paper, “The Multiple Sclerosis Performance Test (MSPT): An iPad-Based Disability Assessment Tool?”
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