Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Leigh R. Hochberg, MD, PhD.3 enrolled

Overview

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

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, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Anarthria Dysarthria Tetraplegia Spinal Cord Injuries Amyotrophic Lateral Sclerosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Between 18 and 80 years of age. * Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases. * Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months. * Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment. Exclusion Criteria: * Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses * Chronic oral or intravenous steroids or immunosuppressive therapy * Other serious disease or disorder that could seriously affect ability to participate in the study (There are additional exclusion criteria)

Locations (2)

Stanford University School of Medicine

Stanford, California, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Device Safety

To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and: 1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period. 2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.

Time frame: 1 year

Secondary Outcomes

Device Feasibility

The purpose of this feasibility measure is to define the metrics by which a larger trial of intracortical recording for the restoration of speech-based communication might be planned. The secondary endpoints are: Number of participants that are able to use the BrainGate system to communicate via speech decoding: 1. at a rate of at least 5 words per minute and 2. with less than a median word error rate of 50%.

Time frame: At participant exit from study, or up to 5 years

Central Contacts

Leigh R Hochberg, MD, Ph.D

CONTACT

617-724-9247 lhochberg@mgh.harvard.edu

Jaimie Henderson, MD