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

Leigh R. Hochberg, MD, PhD.

Status: Enrolling

Conditions: Tetraplegia; Brain Stem Infarctions; Spinal Cord Injuries; Amyotrophic Lateral Sclerosis; Muscular Dystrophy; Locked in Syndrome

Treatments: Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00912041

UH2NS095548 (U.S. NIH Grant/Contract)

U01DC017844 (U.S. NIH Grant/Contract)

A2295-R (Other Grant/Funding Number)

CDMRP-AL220043 (Other Grant/Funding Number)

A4820-R (Other Grant/Funding Number)

U01NS123101 (U.S. NIH Grant/Contract)

MGH-BG2-TP-001

R01DC014034 (U.S. NIH Grant/Contract)

R01DC009899 (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: 27 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
• Complete or incomplete tetraplegia (quadriplegia)
• Must live within a three-hour drive of the Study site
• (There are additional inclusion criteria)

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

BrainGate

Other group

Description:

BrainGate Neural Interface System

Treatment:

Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex