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

NCT07791459 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2026P001792
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Expressive Aphasia; Aphasia Following Cerebral Infarction; Aphasia Following Nontraumatic Intracerebral Hemorrhage; Aphasia Non Fluent

Keywords

Brain-Computer Interface; BCI; Aphasia; Brain-Machine Interface; BrainGate; neuroprosthetic; Neuroport

Outcome Measures

Primary Outcomes (1)

• Safety of the BrainGate2 Neural Interface System

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

  One year post-implant evaluation period

Secondary Outcomes (1)

• Feasibility of speech decoding

  One-year post implant evaluation period

Study Arms (1)

BrainGate Neural Interface System

EXPERIMENTAL

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

Interventions

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.

Also known as: BrainGate, NeuroPort, neural prosthesis, neural prosthetic, neuroprosthetic, brain computer interface, brain-computer interface

BrainGate Neural Interface System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Leigh R. Hochberg, MD, PhD.: lead

MeSH Terms

Conditions

Aphasia, Broca; Aphasia

Interventions

Neural Prostheses; Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants

Study Officials

• Leigh R Hochberg, MD, PhD

  Massachusetts General Hospital

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

617-726-9247; clinicaltrials@braingate.org

Maryam Masood, M.S.

CONTACT

617-726-2241; clinicaltrials@braingate.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2038
• Study Completion (Estimated): December 1, 2038
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: At the time of peer review
• Access Criteria: Public server