Assessment of Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis in 4 Patients: The Stentrode With Thought-Controlled Digital Switch (SWITCH) Study
P. Mitchell, S.C.M. Lee, P.E. Yoo, A. Morokoff, T.J. Oxley, et al.
For: beginner
The problem
Traditional invasive arrays require open craniotomy, and the safety and feasibility of minimally invasive endovascular delivery through the jugular vein remained unknown.
Method
A prospective study enrolled 5 patients with severe bilateral upper-limb paralysis; a Stentrode electrode lattice was delivered by catheter and connected to a subcutaneous unit, with device-related serious adverse events, vessel occlusion, and device migration assessed by CT venography at 3 and 12 months.
Result
Four patients completed 12-month follow-up with no device-related serious adverse events, no vessel occlusion or migration, stable signal, and 5–7 decodable movement types enabling computer tasks at 93.9% selection accuracy.
Why it matters
Establishes endovascular BCI access as a less invasive alternative to open-brain surgery, with a favorable early safety profile.
Limitations
Small sample size (4 patients), a demographically homogeneous group, and only 12 months of follow-up.