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

Status:	Recruiting
Conditions:	Hospital, Neurology, Orthopedic, Psychiatric
Therapuetic Areas:	Neurology, Psychiatry / Psychology, Orthopedics / Podiatry, Other
Healthy:	No
Age Range:	18 - 75
Updated:	4/17/2018
Start Date:	May 2009
End Date:	December 2021
Contact:	Leigh R Hochberg, M.D., Ph.D.
Email:	clinicaltrials@braingate.org
Phone:	617-724-9247

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.

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.

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)

We found this trial at

sites

Providence VA Medical Center

Providence, Rhode Island 02908

Principal Investigator: Stephen Mernoff, M.D.

from

Providence, RI