A surgically implanted brain-computer interface (BCI) has enabled severely paralyzed patients to independently perform important tasks such as online banking, shopping and emailing.
Four patients who participated in the safety and feasibility of the Stentrode with Thought-Controlled Digital Switch (SWITCH) study were caused by amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS). had severe bilateral upper extremity paralysis.
The stent electrode device, called the Stentrode BCI, consists of a net-like material that holds 16 electrodes. A catheter was inserted into the jugular vein and navigated into the superior sagittal sinus (SSS) adjacent to the primary motor cortex. After installation, investigators spread the material flush against the walls of her SSS.
Wires connect the electrodes to a small electronic device on your chest that decodes your conscious thoughts and transmits them wirelessly to your computer.
Dr. Peter Mitchell
Co-principal investigator Peter Mitchell (MBBS, MMed) said he is Director of Neurointerventions at Royal Melbourne Hospital, Australia. Medscape Medical News He is pleased with the results of this first-in-human clinical study of intravascular BCI.
“Patients tolerated the surgery well and were usually discharged within 48 hours,” said Mitchell, who performed the surgery with a team from Royal Melbourne Hospital.
The survey results were published online on January 9. Department of Neurology, JAMA.
>90% accuracy
All four study participants (mean age 61 years) were male, of self-reported European ancestry, and had severe upper extremity paralysis due to ALS (n = 3) or PLS (n = 1).
After the insertion procedure, with training at home and the assistance of a home caregiver trained in the study protocol, the patient used eye tracking to move the computer cursor and identify specific tasks such as composing text messages and emails. task completed.
Stentrode BCI allows severely paralyzed patients to use their thoughts to control digital device systems.
Results showed that patients controlled the system with an average accuracy of 94%.
According to the report, they used the BCI and eye-tracking system to not only compose emails and text messages, but also shop online and perform online banking tasks.
Mitchell and his team followed the patient for 12 months after implantation and noted that there were no serious adverse events (AEs) and the device did not move from its original placement. Non-serious AEs included headache and bruising at the incision site, which were resolved without further complaint.
Next steps include expanding safety studies to additional sites, such as the United States, and “to larger studies with efficacy as the primary endpoint to prove functional benefit.” must be included.
cautiously optimistic
Comments on Medscape Medical News, Dr. Sergei Stavisky, An assistant professor of neurosurgery at the University of California, Davis, Sacramento, said, “Decades of brain-computer interface research have been conducted almost exclusively in academic laboratories, first in preclinical animal models and then in pilot clinical trials. “After being pioneered by , the field is now maturing to the point where multiple start-ups are designing new electrodes and conducting such early safety trials.”
Dr. Sergei Stavisky
Stavisky, who was not involved in the study, said he expected the mechanism used in Stentrode BCI to “very likely work in other patient populations.” The source – here it is the motor cortex – and thus upstream of neurological damage sites across many different conditions.”
So, for example, this could work for patients paralyzed by a subcortical stroke, Stavisky said. “Indeed, other BCI studies have shown impressive results in that patient population.”
“There is an urgent and unmet need for ways to restore lost communication, and I am cautiously optimistic that these recent industry investments will lead to medical devices that begin to fill this need. We do,” said Stavisky.
This study was funded by Synchron, makers of the Stentrode BCI. Mitchell reports receiving institutional research support from Stryker Neurovascular and Medtronic, outside of submitted research. Disclosures to other investigators are fully documented in the original article. Stavisky has not reported any related financial relationships.
Department of Neurology, JAMAPublished online on January 9, 2022.
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