Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked in Syndrome, Muscular Dystrophy, Spinal Cord Injuries, Tetraplegia
Conditions
Keywords
Brain computer interface, Assistive device, Environmental control, Communication device, quadriplegia, tetraplegia
Brief summary
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.
Detailed 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.
Interventions
DEVICEPlacement of the BrainGate2 sensor(s) into the motor-related cortex
Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
Sponsors
Leigh R. Hochberg, MD, PhD.
National Institute on Deafness and Other Communication Disorders (NIDCD)
US Department of Veterans Affairs
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System. | One year post-implant evaluation period |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints. | Course of the study |
Countries
United States
Contacts
CONTACTLeigh R Hochberg, M.D., Ph.D.
PRINCIPAL_INVESTIGATORLeigh R Hochberg, M.D., Ph.D.
Massachusetts General Hospital
Outcome results
None listed