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NCT Number: NCT05724173

Feasibility of the BrainGate2 Neural Interface System in 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

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 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

Stanford University School of Medicine, Stanford, California, United States

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

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 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

Device Safety

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

Device Feasibility

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:

Number of participants that are able to use the BrainGate system to communicate via speech decoding:
- at a rate of at least 5 words per minute and
- with less than a median word error rate of 50%.

Study contacts

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

Jaimie Henderson, MD

CONTACT

[email protected]

650-723-5574

Leigh R Hochberg, MD, Ph.D

CONTACT

[email protected]

617-724-9247

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

Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis

Acronym: BG-Speech-01

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Feb 13, 2023
Registry last updated: Jun 2, 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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