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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLeigh R. Hochberg, MD, PhD.

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Treatments tested in this trial

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

Treatment groups

27 Participants
are divided into 1 treatment group

Sponsors and collaborators

Leigh R. Hochberg, MD, PhD.

Lead sponsor

Massachusetts General Hospital

Sponsor institution

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

US Department of Veterans Affairs

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator