NYU researchers are collaborating with the FDA to develop the first-ever regulatory scientific tool for stroke rehabilitation

Finally someone trying to come up with an objective determination of stroke damage and recovery.

NYU researchers are collaborating with the FDA to develop the first-ever regulatory scientific tool for stroke rehabilitation

Stroke is the most common cause of age-related motor disabilities and is also becoming more common in younger population groups. But while there is a burgeoning market for rehabilitation devices that purport to speed recovery, including robotic rehabilitation systems, recommendations for how and when to use them are based primarily on the subjective assessment of the sensorimotor skills of the patients using them.

S. Farokh Atashzar, assistant professor of electrical, computer, mechanical and aerospace engineering, and biomedical engineering at NYU Tandon School of Engineering and director of the Laboratory of Medical Robotics and Interactive Intelligent Technologies (MERIIT); in collaboration with JohnRoss Rizzo, Associate Professor of Ilse Melamid Associate Professor of Rehabilitation Medicine at NYU School of Medicine, work with Dr. Ramin Bighamian of the U.S. Food and Drug Administration (FDA) to develop a Regulatory Science Tool (RST) that relies on data from biomarkers to improve review procedures for such devices and their optimal use.

The team will develop and validate a robust biomarker of recovery that will enable a first-ever stroke rehabilitation RST based on exchanges between regions of the central and peripheral nervous system.

There is currently no approved RST to evaluate the effectiveness of rehabilitation devices for motor recovery after stroke. This unique collaboration will shed light on how neurological markers can demystify the complex patterns of neuronal communication and realize an objective “neurophysiological window on the deterioration of the interaction between anatomy, activation and signaling pathways in post-stroke patients”.

S. Farokh Atashzar, Assistant Professor of Electrical, Computer, Mechanical and Aerospace Engineering, and Biomedical Engineering, NYU Tandon School of Engineering

The research team will also advance FDA regulatory science on next-generation brain-machine interfaces. In addition, the project will include seminars and undergraduate studies to advance STEM education, with a focus on engaging students from underrepresented groups.

The project is supported by the US National Science Foundation.

“This project illustrates how we are cultivating a highly collaborative research atmosphere—across disciplines like data science and medicine, between Tandon and other schools at NYU, and across the lab and classrooms—as we build our expertise in areas like neural engineering; all with the overarching goal of helping patients,” said Jelena Kovačević, Dean of NYU Tandon. “The importance of this collaboration with NYU School of Medicine speaks for itself, but it’s also encouraging to see that it has been approved by both the FDA as well as confirmed by the NSF.”

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NYU Tandon School of Engineering