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NCT Number: NCT00912041

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

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

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Key information

Conditions

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

University of California, Davis, Sacramento, California, United States

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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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

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

Device

Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.

Other names: BrainGate, NeuroPort, neural prosthesis, neural prosthetic, neuroprosthetic, brain computer interface, brain-computer interface

Primary outcomes

  1. The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.

    Time frame: One year post-implant evaluation period

Secondary outcomes

  1. To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints.

    Time frame: Course of the study

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

Sponsors and collaborators

Lead sponsor

Leigh R. Hochberg, MD, PhD.

Other

Collaborators

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

Registry information

Acronym: BrainGate2

Important dates

Study start
2009
Primary completion
2038
Study completion
2038
First posted
Jun 3, 2009
Registry last updated
Jun 1, 2026

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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