monitoring

Smartphone, wearable device data found reliable to monitor MS: Study

Measurements from smartphones and wearable devices like smartwatches can reliably provide clinically meaningful data to monitor multiple sclerosis (MS), a new study from Switzerland reports. While daily data from such devices did not prove sufficiently reliable in this small study, information generated weekly — across more than 45 different…

Imaging Brain Metabolites May Help Diagnose, Monitor MS

A new imaging technique called magnetic resonance spectroscopic imaging, or MRSI, could be useful for diagnosing and monitoring multiple sclerosis (MS), according to a small study. “If confirmed in longitudinal clinical studies, this new neuroimaging technique could become a standard imaging tool for initial diagnosis, for disease progression and…

Floodlight App Gets Positive Ratings, Shows Good Continuous Use in Pilot Study

Using smartphones and smartwatches to monitor disease course via the FLOODLIGHT app leads to high adherence and satisfaction among patients with multiple sclerosis (MS), results from a pilot study show. The research, “Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study,” was published in the Journal of Medical Internet Research. Assessing MS progression commonly requires periodic in-clinic visits, and doctors may miss subtle changes occurring between such visits. Smartphones may be a solution for real-time data collection and better patient monitoring outside the clinic. The Roche-sponsored FLOODLIGHT study assessed the feasibility of using smartphones and smartwatches to assess MS symptoms, including hand function, gait and posture, mood, and cognitive impairment. FLOODLIGHT primarily evaluated adherence and feedback to the smartphone- and smartwatch-based assessments, as well as the participants’ satisfaction, as determined by their impact on daily activities. The study included 76 MS patients (ages 20 to 57; 53 were women) and 25 healthy controls, who were recruited at the Multiple Sclerosis Centre of Catalonia in Barcelona, and the University of California, San Francisco. Most patients (91%) had relapsing-remitting MS. The mean time since symptom onset was 11.3 years, and the mean Expanded Disability Status Scale score was 2.4. The test battery included active tests performed daily, weekly, every two weeks, or on demand for 24 weeks, and passive monitoring, which analyzed sensor-based gait and mobility. Participants were instructed to complete the active tests at roughly the same time every day, and to carry the smartphone and smartwatch with them all the time. Adherence was assessed via the proportion of weeks with at least three days of completed testing, and four daily hours of passive monitoring. Satisfaction was determined through a questionnaire. Clinical evaluations were conducted at the study's start, after 12 weeks, and at the study's end. Brain magnetic resonance imaging scans were taken at the enrollment visit and at week 24 (study's end). Most participants finished the study – 92% of MS patients and 64% of the controls. Reasons for discontinuation included the burden of continuous monitoring and lack of availability for the three required in-clinic visits. Over an 18-month period, from November 2016 to April 2018, most participants performed five to seven active tests per week, including the Two-Minute Walk Test (2MWT). Adherence to both active tests and passive monitoring for the 24 weeks was good, and remained stable over time after week six. In the final week, participants had a minimum of four hours of passive monitoring data over an average of four days. Adherence was higher for passive monitoring than the tests. Data showed that 70% of participants completed all active tests, 75% did all active tests except the 2MWT, and 79% had data collected via smartphone- or smartwatch-based passive monitoring. The longer a person's disease duration, the lower was their adherence. In contrast, disease severity was not seen to impact adherence. Overall scores reflecting satisfaction was 73.7 out of 100 at week 24, having remained stable since week 12. Sixty-one patients reported that the test battery had an at least an acceptable impact on daily activities. Thirty-two had no issue with the active tests, while one-third would rather avoid the 2MWT. A majority, 60%, of the MS patients said they would like to continue using the FLOODLIGHT app to better understand their disease and improve its management. “Persons with multiple sclerosis were engaged and satisfied with the FLOODLIGHT test battery,” the scientists wrote. As such, “FLOODLIGHT sensor-based measures may enable continuous assessment of multiple sclerosis disease in clinical trials and real-world settings.” FLOODLIGHT tests are being assessed in long-term studies with larger patient groups in the CONSONANCE Phase 3b trial of Ocrevus (ocrelizumab, by Roche-owned Genentech) in people with progressive MS still enrolling, contact information is here), and in a global study open to all MS patients with a mobile device, called FLOODLIGHT Open.

Consortium of Multiple Sclerosis Centers Revises MRI Guidelines

The Consortium of Multiple Sclerosis Centers has updated guidelines for using magnetic resonance imaging to evaluate people suspected of having multiple sclerosis. Doctors use the MRI guidelines not only to diagnose MS but also to track treatment results. A task force is reviewing the new guidelines before they're published. The working document is called  "Revised Guidelines of the CMSC MRI Protocol for the Diagnosis and Follow-up of MS." The task force, composed of neurologists, radiologists and imaging scientists experienced in MS, met in January 2017 to revise the guidelines. They also updated information about the situations for which standardized brain and spinal cord MRI scans should be used. One change is a recommendation that gadolinium, a contrast agent in scans, be used cautiously. The previous update, published in 2015, included no constraints on the use of gadolinium-based contrast agents. But soon after publication, information emerged showing that gadolinium, although not toxic, accumulates in the brain. This prompted the U.S. Food and Drug Administration to recommend limiting the use of gadolinium to “appropriate clinical circumstances.” To mirror the increased awareness of gadolinium deposits, the new guidelines say: “While there is no known central nervous system toxicity, these agents should be used judiciously, recognizing that gadolinium continues to play an invaluable role in specific circumstances related to the diagnosis and follow-up of individuals with MS.” Since 2009, the Consortium of Multiple Sclerosis Centers has addressed a number of other issues. One is encouraging the use of three-dimensional MRI for brain scans. Another is developing protocols for monitoring severe optic nerve inflammation and progressive multifocal leukoencephalopathy, or PML, a brain disease caused by a virus. The guidelines have been revised to recommend the specific timing of scans for monitoring PML. The update also includes recommendations for the timing of scans on patients receiving disease-modifying drugs. Since 2009, the guidelines have included recommendations on scans of radiologic isolated syndrome, a condition where MS-like MRI lesions are present without symptoms. And they have included provisions on the value of using MRI changes to evaluate treatment effectiveness. The centers' goal "is to standardize the MRI protocol and make these recommendations a useful guideline for neurologists, neuroradiologists, and related healthcare professionals during initial evaluations and during follow-up of patients with MS, and ultimately provide optimum care for those individuals dealing with this unpredictable disease,” June Halper, the centers' chief executive officer, said in a press release.