BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia "BrainGate2"

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility of efficacy) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

Detailed Description

The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis to recover a host of abilities that normally rely on the hands.

Conditions

Interventions

  • Placement of the BrainGate2 sensor into the motor cortex Device
    Other Names: BrainGate; NeuroPort; neural prosthesis; neural prosthetic; neuroprosthetic; brain computer interface; brain-computer interface
    Intervention Desc: The 4x4 mm BrainGate2 sensor is placed into the motor cortex, connected to a percutaneous pedestal. Neural recordings are made at least weekly for a year or more.
    ARM 1: Kind: Experimental
    Label: BrainGate
    Description: BrainGate Neural Interface System
  • Placement of the BrainGate2 sensor(s) into the motor-related cortex Device
    Other Names: BrainGate; NeuroPort; neural prosthesis; neural prosthetic; neuroprosthetic; brain computer interface; brain-computer interface
    Intervention Desc: One or two 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex, connected to a percutaneous pedestal. Neural recordings are made at least weekly for a year or more.
    ARM 1: Kind: Experimental
    Label: BrainGate
    Description: BrainGate Neural Interface System

Trial Design

  • Masking: Open Label
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System. One year post-implant evaluation period Yes
Secondary To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints. Course of the study No

Sponsors