思考を行動に移すブレイン・コンピューター・インターフェースの臨床試験で、優れた安全性プロファイルを確認(Clinical trials show encouraging safety profile for brain-computer interface turning thoughts into action)


神経インターフェースシステム「ブレインゲート」が有害事象の発生を抑制することを確認。 In an important step toward a medical technology that could help restore independence of people with paralysis, researchers find the investigational BrainGate neural interface system has low rates of associated adverse events.

2023-01-13 ブラウン大学

Brain-computer interfaces use tiny electrodes to record signals in the brain. Credit: BrainGate.org.



BrainGate神経インターフェースシステムのフィージビリティスタディにおける安全性プロファイルの中間報告 Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System

Daniel B Rubin, A. Bolu Ajiboye, Laurie Barefoot, Marguerite Bowker, Sydney S. Cash, David Chen, John P Donoghue, Emad N Eskandar, Gerhard Friehs, Carol Grant, Jaimie M Henderson, Robert F Kirsch, Rose Marujo, Maryam Masood, Stephen T Mernoff, Jonathan P Miller, Jon A Mukand, Richard D Penn, Jeremy Shefner, Krishna V Shenoy, John D Simeral, Jennifer A Sweet, Benjamin L Walter, Ziv M Williams, Leigh R Hochberg
Neurology  Published January 13, 2023
DOI: https://doi.org/10.1212/WNL.0000000000201707


Background and Objectives: Brain computer interfaces (BCIs) are being developed to restore mobility, communication, and functional independence to people with paralysis. Though supported by decades of preclinical data, the safety of chronically implanted microelectrode array BCIs in humans is unknown. We report safety results from the prospective, open-label, non-randomized BrainGate feasibility study (NCT00912041), the largest and longest-running clinical trial of an implanted BCI.

Methods: Adults aged 18-75 with quadriparesis from spinal cord injury, brainstem stroke, or motor neuron disease were enrolled through seven clinical sites in the United States. Participants underwent surgical implantation of one or two microelectrode arrays in the motor cortex of the dominant cerebral hemisphere. The primary safety outcome was device-related serious adverse events requiring device explanation or resulting in death or permanently increased disability during the one-year post-implant evaluation period. Secondary outcomes include the type and frequency of other adverse events as well as the feasibility of the BrainGate system for controlling a computer or other assistive technologies.

Results: From 2004 – 2021, fourteen adults enrolled in the BrainGate trial had devices surgically implanted. The average duration of device implantation was 872 days, yielding 12,203 days of safety experience. There were 68 device-related adverse events, including 6 device-related serious adverse events. The most common device-related adverse event was skin irritation around the percutaneous pedestal. There were no safety events that required device explantation, no unanticipated adverse device events, no intracranial infections, and no participant deaths or adverse events resulting in permanently increased disability related to the investigational device.

Discussion: The BrainGate Neural Interface system has a safety record comparable to other chronically implanted medical devices. Given rapid recent advances in this technology and continued performance gains, these data suggest a favorable risk/benefit ratio in appropriately selected individuals to support ongoing research and development.

Trial Registration Information: ClinicalTrials.gov Identifier: NCT00912041.

Classification of Evidence: This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs defined as those requiring device explanation, resulting in death, or resulting in permanently increased disability during the one-year post implant period.