Clinical Research Directory

Digital Tools for Assessment of Motor Functions and Falls in ALS

This is a 48-week single arm study that incorporates digital tools for assessing motor function as part of an ALS telemonitoring program. During the study, neck- and wrist-worn "activity sensors" (PAMSys, BioSensics, Newton, MA) that will be worn by subjects while performing tasks of daily living. Subjects will also complete a motor, speech, and handwriting assessment during site visits. Subjects will complete a digital home assessments of speech, handwriting, and pattern tracing tasks throughout the study, and report any falls which occur on the study tablet. The investigators will explore whether functional changes are sensitive to self-reported changes on the ALS Functional Rating Scale - Revised (ALFRS-R) over the length of the study.

ALS/MND Natural History Study Data Repository

This is a data repository for multi-site multi-protocol clinic-based Natural History Study of ALS and Other Motor Neuron Disorders (MND). All people living with ALS or other MNDs who attend clinics at the Study hospitals (sites) are offered to participate in the Study. The Sites collect so-called Baseline information including demographics, disease history and diagnosis, family history, etc. At each visit, the Sites also collect multiple disease-specific outcome measures and events. The information is captured in NeuroBANK, a patient-centric clinical research platform. The Sites have an option to choose to collect data into 20+ additional forms capturing biomarkers and outcome measures. Captured data after its curation are anonymized (all personal identifiers and dates are being removed), and the anonymized dataset is shared with medical researchers via a non-exclusive revocable license. Funding Source - Biogen, Inc.; Mitsubishi Tanabe Pharma America; FDA OOPD.