The Stentrode represents an advancement in neurotechnology, offering a novel approach to brain-computer interfaces (BCIs). This device aims to help individuals with severe paralysis or neurological conditions regain functional independence and communication abilities. Its unique, minimally invasive design allows for implantation without requiring open brain surgery, distinguishing it from other BCI technologies. The Stentrode’s development marks a step forward in creating digital bypasses from the brain to assistive devices.
Understanding the Stentrode
The Stentrode is a small, flexible neuroprosthesis device that is implanted within a blood vessel in the brain. It measures about 5 cm long and can expand up to 8 mm in diameter. This device functions as an electrode array, equipped with electrodes on its surface to record neural signals directly from within the blood vessel.
Unlike traditional brain-computer interfaces that require invasive brain surgery to place electrodes directly on or into brain tissue, the Stentrode utilizes an endovascular approach. This method allows the device to be positioned adjacent to the motor cortex, the brain region responsible for voluntary movement, without direct penetration or damage to brain tissue.
How Stentrode Technology Operates
The Stentrode detects neural signals from blood vessels. Electrodes pick up electrical frequencies from motor cortex neurons. These signals represent the patient’s intended actions or thoughts, even if their body cannot perform the movements.
Once detected, these neural signals transmit wirelessly from the Stentrode to an external processing unit. This unit, often implanted in the chest, then relays the information to an external receiver. Specialized software processes these signals, translating brain activity into actionable commands, such as controlling a computer cursor or generating keystrokes. This allows individuals to interact with digital devices using only their thoughts.
Medical Applications and Patient Impact
The Stentrode assists individuals with severe paralysis from neurological conditions. These conditions include amyotrophic lateral sclerosis (ALS), spinal cord injury, and stroke, which can severely limit communication or movement. It offers a potential pathway to restore communication and functional independence.
For patients with ALS, who progressively lose movement and speech, the Stentrode could enable them to control digital devices using their thoughts. Similarly, individuals with spinal cord injuries or stroke-induced paralysis may regain the ability to interact with their environment. Examples of its potential use include controlling a computer cursor to type messages, send emails, or engage in online shopping and banking. The technology also shows promise for controlling assistive devices, such as robotic prostheses or exoskeletons, enhancing mobility.
The Stentrode Implantation Procedure
Stentrode implantation involves a minimally invasive surgical procedure leveraging existing endovascular techniques. A catheter is inserted into a blood vessel, typically the jugular vein in the neck. The catheter guides through the vascular system to the brain’s motor cortex, where the Stentrode deploys.
Once in position, the Stentrode expands to gently press its electrodes against the vessel wall, allowing it to record neural activity. This method avoids the need for open-brain surgery, which traditionally involves drilling into the skull. The endovascular approach reduces surgical risks, such as infection and trauma to brain tissue. The procedure generally takes about two hours in a hospital, often an angiography suite. Patients typically can go home within 48 hours after the procedure.
Current Research and Development Status
The Stentrode is currently undergoing clinical trials to assess its safety and efficacy. It received FDA Breakthrough Device designation in August 2020 and an Investigational Device Exemption (IDE) in July 2021, allowing for the US COMMAND clinical trial. This study, including patients with severe paralysis, evaluates the device’s ability to facilitate hands-free digital device control.
Initial studies, such as the SWITCH trial in Australia, have shown promising results, demonstrating that the Stentrode can be safely implanted and used without serious adverse events over a one-year period. In these trials, participants with ALS successfully used the device to communicate and perform daily online tasks. Synchron, the Stentrode’s developer, plans a pivotal trial aiming for eventual FDA approval and wider commercial availability within four to five years.