$2.9M to Mount Sinai to Study Implant for Paralyzed Patients

The National Institutes of Health (NIH) has awarded $2.9 million to New York’s Mount Sinai to study whether a never-before-seen brain implant can help severely paralyzed patients communicate. The grant, part of a $10 million award that goes toward a multicenter clinical trial for the first U.S. implantation, could lead to results that yields improved daily life for these patients.

“Unlike all other invasive brain-computer interface technology up until this point, the Stentrode implantation procedure does not require open brain surgery, meaning that the patient’s skull remains intact, their brain tissue is not directly penetrated by the electrodes and the risk of complication is much lower.,” says David Putrino, P.T., Ph.D. is director of Rehabilitation Innovation at the Mount Sinai Health System and associate professor of Rehabilitation and Human Performance at the Icahn School of Medicine at Mount Sinai in Manhattan.

Synchron, Inc., headquartered in New York, New York, developed the Stentrode device, a small brain-computer interface implanted through blood vessels in the brain. Mount Sinai researchers will investigate how implantation of this device in six patients with severe paralysis, caused by stroke, injury, or late-stage amyotrophic lateral sclerosis (Lou Gehrig’s disease), can improve quality of life, daily function, and health outcomes.

“Neurointerventionalists implant the Stentrode using a catheter during a minimally invasive procedure,” according to Mount Sinai. “It goes through the jugular vein and into a large vessel near the primary motor cortex—the area of the brain that is responsible for producing movement commands. The Stentrode is the only brain-computer interface that can access the primary motor cortex with this approach, without requiring open brain surgery.”

How does the Stentrode detect brain signals that facilitate movement? Dr. Putrino explained, “Once the Stentrode is placed in the blood vessel, it actually heals into the vessel wall and from that vantage point, the electrode can detect electrical impulses produced by the neurons in the brain that are near the blood vessel that the electrode is placed in. The neurons near the Stentrode are part of the primary motor cortex, meaning they are most active when we try to produce voluntary movement. So, once the Stentrode is placed and is recording activity from nearby motor cortex neurons, when the user thinks about moving a body part, it produces a unique brain activity signature that the Stentrode software can recognize and use as a control signal.”

Recent research published in the Journal of NeuroInterventional Surgery found that two Australian patients implanted with the Stentrode learned to control texting and typing via direct thought. These individuals were capable of using the system unsupervised in their homes to send text messages, do online shopping, and handle their personal finances.

Dr. Putrino, principal investigator of the study, explained the objectives of the current study to OTW, “The goal of the current clinical trial is to use the Stentrode technology to allow someone who is severely paralyzed to achieve independent control of a computer by using thought-controlled signals to control a cursor on a computer screen and click on command.”

“To date, no one has achieved independent home use of an implanted brain computer interface device. Most of the brain-computer interface devices out there are part of important research initiatives, but they aren’t directly being used by patients on a daily basis to improve quality of life. What excites me about this work is that the Stentrode is a device that is designed to for patients, not research. I think it has a lot of potential to improve people’s lives.”