BrainGate2 for Tetraplegia and Other Motor Neuron Disorders

This study is testing the BrainGate2 Neural Interface System, which involves placing small sensors into the part of the brain that controls movement. The goal is to see if people with tetraplegia (paralysis affecting all four limbs) due to conditions like spinal cord injury, ALS, or brainstem stroke can use their thoughts to control a computer cursor and other assistive devices. Researchers want to make sure the BrainGate2 system is safe, which will be evaluated one year after the sensors are put in. The study is currently looking for up to 27 participants between 18 and 80 years old who live within a three-hour drive of the study site and have complete or incomplete tetraplegia. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 27 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will have up to six BrainGate2 sensors placed into their motor-related cortex. Neural recordings will be made at least weekly for a year or more.
Compensation
Not stated in the trial record.
Follow-up
Safety will be evaluated one year after the sensors are implanted.

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NCT00912041

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

Recruiting
NAAges 18–80Interventional
Leigh R. Hochberg, MD, PhD.
~27 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Placement of the BrainGate2 sensor(s) into the motor-related cortex

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.
Measured over One year post-implant evaluation period
Tetraplegia
Spinal Cord Injuries
Amyotrophic Lateral Sclerosis
Brain Stem Infarctions
Locked in Syndrome
Muscular Dystrophy
6 sites across 5 states
California2
Georgia1
Massachusetts1
Rhode Island1
Texas1
  • Leigh R Hochberg, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

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

Exclusion

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