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NCT Number: NCT06094205

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

The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.

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Key information

Conditions

Anarthria Amyotrophic Lateral Sclerosis Articulation Disorders Brain Diseases Brain Infarction Brain Ischemia Brain Stem Infarctions Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dysarthria Genetic Diseases, Inborn Infarction Ischemia Language Disorders Locked-In Syndrome Metabolic Diseases Motor Neuron Disease Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Necrosis Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Quadriplegia Signs and Symptoms Speech Disorders Spinal Cord Diseases Spinal Cord Injuries Stroke TDP-43 Proteinopathies Tetraplegia Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interface". The implanted medical device measures the person's brain activity as they try to talk and outputs their intended speech. By bypassing the injured parts of the nervous system this way, we can observe how individual brain cells are involved in speaking and working together as a network, to produce speech, and we can learn to decipher this activity to output what the person is trying to say.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

(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)

Treatment and study plan

BrainGate Neural Interface System

Device

Placement of the BrainGate2 sensor(s) into the speech-related cortex

Primary outcomes

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

    Time frame: 1 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:

    • the sensors are not explanted for safety reasons during the one-year post-implant evaluation period.
    • there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.

Secondary outcomes

  1. Decoded speech output accuracy

    Time frame: At participant exit from study, or up to 5 years

    The purpose of this feasibility measure is to define the metrics by which a larger trial of intracortical recording for the restoration of speech-based communication might be planned. The secondary endpoints are:

    • The word error rate of speech that is output by the System
    • The phoneme error rate of speech that is output by the System

Study contacts

Contact information is provided by the study sponsor or research team.

Leigh R. Hochberg, M.D., Ph.D.

CONTACT

[email protected]

617-724-9247

Sergey Stavisky, Ph.D.

CONTACT

[email protected]

530-754-3413

Sponsors and collaborators

Lead sponsor

Leigh R. Hochberg, MD, PhD.

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface

Acronym: BG-Speech-02

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2023
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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