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

NCT00912041 · Massachusetts General Hospital

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study

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.

Eligibility criteria

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)

Study design

Enrollment target: 27 participants

Allocation: na

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2009-05

Estimated completion: 2038-12

Last updated: 2025-12-03

Interventions

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

Primary outcomes

• The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System. (One year post-implant evaluation period)

Sponsor

Leigh R. Hochberg, MD, PhD. · other

With: National Institute on Deafness and Other Communication Disorders (NIDCD), US Department of Veterans Affairs, National Institute of Neurological Disorders and Stroke (NINDS)

Contacts & investigators

ContactLeigh R Hochberg, M.D., Ph.D. · contact · clinicaltrials@braingate.org · 617-724-9247

InvestigatorLeigh R Hochberg, M.D., Ph.D. · principal_investigator, Massachusetts General Hospital

All locations (5)

University of California, DavisRecruiting

Sacramento, California, United States

Stanford University School of MedicineRecruiting

Stanford, California, United States

Emory University School of MedicineRecruiting

Atlanta, Georgia, United States

Massachusetts General HospitalRecruiting

Boston, Massachusetts, United States

Providence VA Medical CenterRecruiting

Providence, Rhode Island, United States

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