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

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with aphasia to generate text on a computer screen and audible, computer-generated speech by attempting to speak.

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Key information

Conditions

Expressive Aphasia Aphasia Aphasia Following Cerebral Infarction Aphasia Following Nontraumatic Intracerebral Hemorrhage Aphasia Non Fluent Aphasia, Broca Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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 or aphasia, 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 expressive aphasia due to ischemic or hemorrhagic stroke (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

Up to six 4x4 mm BrainGate sensor(s) are placed into the speech or language-related 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

Safety of the BrainGate2 Neural Interface System

Time frame: One year post-implant evaluation period

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

Secondary outcomes

Feasibility of speech decoding

Time frame: One-year post implant evaluation period

The secondary endpoints of this Study are to investigate the feasibility of the BrainGate system and to establish the parameters for a larger clinical study, The main secondary endpoint is the ability of the system to decode neural signals related to speech / language generation into output for text- and/or speech- generating devices.

Study contacts

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

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

CONTACT

[email protected]

617-726-9247

Maryam Masood, M.S.

CONTACT

[email protected]

617-726-2241

Sponsors and collaborators

Lead sponsor

Leigh R. Hochberg, MD, PhD.

Other

Registry information

Acronym: BG2-Aphasia

Important dates

Study start: 2026
Primary completion: 2038
Study completion: 2038
First posted: Aug 28, 2026
Registry last updated: Aug 31, 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.

Published trials that share one or more normalized conditions with this study.

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