The US Food and Drug Administration (FDA) has granted approval for an investigational device exemption (IDE) application by the University of Washington School of Medicine to conduct an early feasibility study using CorTec’s Brain Interchange implant system.

This study will explore the potential of cortical stimulation in stroke rehabilitation to enhance brain plasticity by utilising the closed-loop Brain Interchange implant system.

The Brain Interchange System is a fully implantable closed-loop brain-computer interface (BCI) that has now been cleared for human use. This technology is expected to open new avenues for the investigation of therapies for neurological diseases.

CorTec chief technology officer Dr Martin Schuettler said: “The system is capable of interchanging information between biology and technology, between brain and computer. That’s why we call it CorTec Brain Interchange.

“With our system, we are providing the technological tools that are needed to develop new therapies and brain-computer interface applications.”

The IDE study, which marks the first human application of the Brain Interchange System, is planned to be conducted in collaboration with experts in the field.

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Principal investigator professor Jeffrey Ojemann from the University of Washington School of Medicine, along with professor Steven Cramer from the University of California Los Angeles and their teams, will spearhead the research.

Funded by the US National Institutes of Health (NIH), the consortium’s goal is to gather initial safety data and develop and assess new therapeutic rehabilitation strategies for upper limb impairment in stroke patients.

The Brain Interchange System will deliver direct cortical electrical stimulation as part of the treatment.

Patient enrolment and the inaugural implantation of the neural interfacing system are scheduled for the third quarter of 2024.

This study could pave the way for innovative treatments that could significantly impact stroke rehabilitation practices.