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BrainGate2 Neural Interface System for Speech in Tetraplegia

This study is testing the BrainGate2 Neural Interface System, a device that is placed in the brain, to help people with conditions like spinal cord injury or ALS who have lost the ability to speak. The goal is to understand how the brain produces speech and to develop a way for people to communicate using a computer just by trying to speak. The study is looking for two participants, aged 18 to 80, who have complete or incomplete tetraplegia (quadriplegia). Success in this study means the sensor stays implanted for at least one year without serious problems or needing to be removed. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of two participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to have the sensor implanted for at least one year without issues.

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NCT06094205

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

Recruiting
NAAges 18–80Interventional
Leigh R. Hochberg, MD, PhD.
~2 participants
Updated 2025-12-01 on ClinicalTrials.gov
What's tested:BrainGate Neural Interface System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
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

1 sites across 1 states
California1

Study leadership

  • Sergey Stavisky, Ph.D. · PRINCIPAL_INVESTIGATOR · University of California, Davis

Who to contact

Leigh R. Hochberg, M.D., 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
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 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

  • Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant1 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.