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BrainGate2 System for Communication in Tetraplegia

This study is testing the BrainGate2 Neural Interface System in people with tetraplegia (paralysis of all four limbs) who also have anarthria (inability to articulate speech) or severe dysarthria (difficulty speaking). The BrainGate2 system involves placing small sensors into the part of the brain that controls speech. The main goal is to see if the device is safe over one year and to show that people can use their thoughts to control a computer cursor and other assistive devices. You may be able to join if you are between 18 and 80 years old and have a diagnosis of ALS (amyotrophic lateral sclerosis) with severe speech difficulties. This study plans to enroll 3 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 3 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for device safety for 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05724173

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Recruiting
NAAges 18–80Interventional
Leigh R. Hochberg, MD, PhD.
~3 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:BrainGate Neural Interface System

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device Safety
Measured over 1 year

Conditions

Anarthria
Dysarthria
Tetraplegia
Spinal Cord Injuries
Amyotrophic Lateral Sclerosis
Brain Stem Infarctions
Locked in Syndrome
Muscular Dystrophies

Explore related trials

Amyotrophic Lateral SclerosisAnarthriaBrain stem infarctionDysarthriaLocked-In StateMuscular DystrophyQuadriplegiaSpinal Cord Injury

Where it's being run

2 sites across 2 states
California1
Massachusetts1

Study leadership

  • Jaimie Henderson, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Leigh R Hochberg, MD, Ph.D
[email protected]
617-724-9247
Email the study team

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Eligibility criteria

Inclusion

Between 18 and 80 years of age.
Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

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

What this trial measures

  • Device Safety1 year

    To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and: 1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period. 2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.