Long-Term Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis

Research Objectives

This first-in-human study assessed safety of an implanted brain-computer interface (BCI). Secondary objective was feasibility of using the implant as a motor neuron prosthesis (MNP) to control a computer by thought.

Design

First-in-human, single arm, open-label, prospective study with 12-month follow up.

Setting

The implant procedure and follow-up visits were performed at Royal Melbourne Hospital in Australia; training and device usage were performed in clinic and at home with a caregiver present.

Participants

Five subjects were enrolled in the study, and four met the preoperative requirements and received the device implant. Age at enrolment was 61±17 years. All subjects were males with paralysis from amyotrophic lateral sclerosis. Subjects had varying impairment in lung function and speech capability at enrollment.

Interventions

Subjects were implanted with a device (Stentrode, Synchron, Brooklyn, NY) in the largest blood vessel of the brain using venous access. The device was connected to an electronics unit in a subcutaneous pocket that wirelessly communicates through the skin to an external device to allow laptop computer control.

Main Outcome Measures

Primary safety endpoint was device-related serious adverse events resulting in death or permanent increased disability within 12 months after implant. Secondary safety endpoints were target vessel occlusion and incidence of device migration, evaluated 3 and 12 months after implant. The study recorded signal fidelity and stability over 12 months and use of the MNP to perform routine digital tasks.

Results

All four implanted subjects completed the 12-month follow-up with no serious adverse events. Post-operative imaging found no occlusion of the blood vessels or device migration. All implanted subjects successfully used the MNP for computer use in the home.

Conclusions

The study met all safety endpoints, and subjects could use the endovascular MNP to perform digital tasks on a computer.

Author(s) Disclosures

Dr. Oxley is chief executive officer of Synchron and holds stock options and patents on the technology used in the study.