Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

Brain-Computer InterfaceBCIAphasiaBrain-Machine InterfaceBrainGateneuroprostheticNeuroport

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 SystemDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Leigh R. Hochberg, MD, PhD.
Otherlead

MeSH Terms

Conditions

Aphasia, BrocaAphasia

Interventions

Neural ProsthesesBrain-Computer Interfaces

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

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

November 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

September 2038

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

BrainGate Neural Interface System

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

BrainGate Neural Interface System

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record