Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-01)

Leigh R. Hochberg, MD, PhD.

Status

Enrolling

Conditions

Anarthria

Tetraplegia

Brain Stem Infarctions

Spinal Cord Injuries

Dysarthria

Amyotrophic Lateral Sclerosis

Muscular Dystrophies

Locked in Syndrome

Treatments

Device: BrainGate Neural Interface System

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05724173

2022p003220 (BG-Speech-01)

U01DC019430 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

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

Enrollment

3 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)