NIH Grants $10M to US Trial of Stentrode Brain Implant for Paralysis
A $10-million grant from the National Institutes of Health (NIH) will help fund the first U.S.-based clinical trial of Synchron’s Stentrode, a wireless brain device, implanted without open brain surgery, that transmits signals from the brain directly to a computer.
The COMMAND trial will evaluate whether the device can help people with severe paralysis — including those with amyotrophic lateral sclerosis (ALS) — regain functional independence and the ability to communicate digitally.
The grant will be managed by Carnegie Mellon University, in Pittsburgh, while recruitment and study procedures will be conducted at the University of Pittsburgh Medical Center and Mount Sinai Health System. Approved by the U.S. Food and Drug Administration (FDA) in July, the study will enroll six patients and is expected to start later this year.
“This significant investment by NIH reflects the mature stage of Synchron’s technology,” Thomas Oxley, MD, PhD, CEO of Synchron, said in a press release. “We are excited to be collaborating with three world-leading U.S. institutions to deliver on the long promise of brain computer interface technology.”
Stentrode is a minimally invasive device that works to transmit signals from the brain’s motor cortex — a region responsible for voluntary movement — into a computer.
While most similar devices require open brain surgery for implantation, Stentrode is inserted via a small incision in the neck, moved through the jugular vein, and placed precisely in the blood vessels next to the motor cortex. The procedure is similar to that used to treat strokes, the company says.
Stentrode then expands and grows into vessel walls without blocking blood flow.
When the device captures brain activity associated with intended movement, it sends these signals through a wire to a small sensor implanted just under the skin on the chest, which then wirelessly transmits the data to a computer or smartphone.
This enables patients to use their thoughts and eye movements to control a cursor on the screen and keyboard commands, helping them communicate with their caregivers and medical professionals, and regain the ability to perform daily tasks such as texting and online shopping.
“We have overcome technical problems that have previously restricted clinical translation of [brain computer interfaces]: it is wireless, mobile, fully implantable, and does not require open brain surgery or robots,” said Oxley.
Synchron is currently investigating its device in an Australia-based clinical trial (NCT03834857), which is entering its third year. The SWITCH trial has implanted the device in four severely paralyzed patients, including two with ALS.
These two patients had lost the ability to use a computer or a smartphone due to loss of control of their upper limbs. However, within a few months of Stentrode implantation, patients, unsupervised in their homes, were able to control a computer and complete daily tasks such as online banking, shopping, and texting.
Patients achieved a mean mouse click accuracy of at least 92% and were able to type between 14 and 20 characters per minute without additional help.
“This technology has the potential to revolutionize our ability to care for patients by solving health challenges that have previously been insurmountable including communication with patients with certain types of paralysis,” said David Putrino, PhD, director of Rehabilitation Innovation for the Mount Sinai Health System, and associate professor of Rehabilitation Medicine at Icahn School of Medicine at Mount Sinai.
Last year, Stentrode received the FDA’s designation of breakthrough device, meant to accelerate the development and review of devices that might more effectively treat or diagnose life-threatening or irreversibly debilitating diseases.