August 2022 | Issue 47
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Following the first endovascular implantation of Synchron’s Stentrode brain-computer interface (BCI) device in the USA, physicians have highlighted the wider significance of this breakthrough case—not only in progressing a technology that stands to fulfil an unmet need for patients with severe paralysis, but also by illuminating new frontiers that may be on the horizon for neurointerventional surgery.
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principal investigator David Putrino (Mount Sinai Health System, New York, USA).
First COMMAND patient
Majidi began his presentation of this milestone procedure at SNIS 2022 by noting that more than five million people in the USA alone suffer from severe paralysis, with the majority being completely dependent on caregivers to fulfil their basic daily needs. The COMMAND study was set up to assess the Stentrode’s potential in improving functional independence for these patients by restoring neural signal transmission from the cerebral cortex and executing digital commands—with a total planned enrolment of six quadriparesis patients. “Our first patient is a 67-year-old gentleman with severe quadriplegia from ALS [amyotrophic lateral sclerosis] on a ventilator,” Majidi reported, stating that pre-implant imaging included a magnetic resonance cerebral venogram and structural magnetic resonance imaging (MRI). He further noted that MRI markers were later co-registered into a live angiography and provided a “roadmap to ascertain accurate deployment of the device”. Detailing the Stentrode implantation, Majidi said right internal jugular venous access was obtained to reach the ‘point of interest’ in the superior sagittal sinus. Once visual markers had been established on imaging, a 6Fr guide
This is an incredibly exciting milestone for the field, because of its implications and huge potential.” Shahram Majidi
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Late-breaking studies lead 2022 INS congress THIS EDITION OF NEURONEWS homes in on this year’s International Neuromodulation Society (INS) congress (21–26 May 2022, Barcelona, Spain), featuring three latebreaking presentations from the event. In Barcelona, INS president Marc Russo (Newcastle, Australia) demonstrated what he believes is a “true breakthrough” in pain management—a novel spinal cord stimulation (SCS) technique centred around the dorsal horn dendrite. New data on the safety of deep brain stimulation (DBS) in Huntington’s disease patients and occipital nerve stimulation (ONS) for chronic cluster headache were delivered by Jan Vesper (Düsseldorf, Germany) and Frank Huygen (Rotterdam, The Netherlands), respectively. In addition to further clinical studies and the latest industry news, this issue also features insights on female representation in the brain stimulation field, with a progress update from several members of the Women in Neuromodulation (WiN) group, and highlights the eight phaseone winners for the US$9.8 million Neuromod Prize. To read about these breakthroughs and insights, and much more from the world of neuromodulation, turn to page 21.
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First US Stentrode implant heralds new field in neurointervention ynchron recently announced the successful completion of the first implant in its US COMMAND study, with lead clinical investigator Shahram Majidi (Mount Sinai Health System, New York, USA) delivering a detailed presentation of this case for the first time at the Society of NeuroInterventional Surgery’s (SNIS) 19th annual meeting (25–29 July, Toronto, Canada). “This is an incredibly exciting milestone for the field, because of its implications and huge potential,” said Majidi, who performed this novel procedure at Mount Sinai. “The implantation procedure went extremely well, and the patient was able to go home 48 hours after the surgery.” COMMAND, a prospective, open-label, single-arm, early feasibility study, is being conducted under what Synchron claims is the first investigational device exemption (IDE) awarded by the US Food and Drug Administration (FDA) to a company assessing a permanently implanted BCI. It is intended to assess the safety and efficacy of the company’s motor BCI technology platform, including the Stentrode device, in patients with severe paralysis—with the goal of utilising patient brain data to enable them to control digital devices hands-free and, ultimately, achieve improvements in functional independence. “We are beyond excited to get to work with our patient, guiding them through the training process as they learn to use this device to live more independently and, most importantly, communicate with their family ai16605680847_CXAV2022 NN FP BANNER 225X55.pdf 1 15/08/2022 13:54:45 and friends,” said COMMAND
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