BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG2-Aphasia)

August 27, 2026 updated by: Leigh R. Hochberg, MD, PhD.
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BrainGate Neural Interface System
Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex. Up to six 4x4 mm NeuroPort or MultiPort sensor(s) are placed into the speech or language areas of cortex, connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
Device: BrainGate Neural Interface System
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:
  • neuroprosthetic
  • brain-computer interface
  • NeuroPort
  • BrainGate
  • neural prosthesis
  • neural prosthetic
  • brain computer interface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year post-implant evaluation period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One-year post implant evaluation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leigh R. Hochberg, MD, PhD.

Investigators

  • Study Director: Leigh R Hochberg, MD, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

September 1, 2038

Study Completion (Estimated)

December 1, 2038

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026P001792

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Neural data supporting peer-reviewed publications

IPD Sharing Time Frame

At the time of peer review

IPD Sharing Access Criteria

Public server

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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