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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: Leigh R. Hochberg, MD, PhD.

Current Primary Outcome: The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System. [ Time Frame: One year post-implant evaluation period ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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. [ Time Frame: Course of the study ]

Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: June 1, 2009
Date Started: May 2009
Date Completion: December 2021
Last Updated: September 12, 2016
Last Verified: September 2016