Expressive AphasiaBG2-AphasiaNCT07791459
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia
A study testing BrainGate Neural Interface System in people with Expressive Aphasia and Aphasia Following Cerebral Infarction, run by Leigh R. Hochberg, MD, PhD..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Expressive Aphasia, Aphasia Following Cerebral Infarction, Aphasia Following Nontraumatic Intracerebral Hemorrhage
- What is being tested?
- BrainGate Neural Interface System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2038
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of expressive aphasia due to ischemic or hemorrhagic stroke (There are additional inclusion criteria)
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Expressive Aphasia, Aphasia Following Cerebral Infarction, Aphasia Following Nontraumatic Intracerebral Hemorrhage, Aphasia Non Fluent
- Being tested
- BrainGate Neural Interface System
- Keywords
- Brain-Computer Interface, BCI, Aphasia, Brain-Machine Interface, BrainGate, neuroprosthetic, Neuroport
- Medical subject headings
- Aphasia, Broca, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainGate Neural Interface SystemDevice
Also called BrainGate, NeuroPort, neural prosthesis, neural prosthetic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BrainGate Neural Interface System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the BrainGate2 Neural Interface System
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System
Measured: One year post-implant evaluation period
Secondary outcomes (1)
Feasibility of speech decoding
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.
Measured: One-year post implant evaluation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2038 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Expressive AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leigh R. Hochberg, MD, PhD.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
- Investigators
- Leigh R Hochberg, MD, PhD, Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791459
- Sponsor's protocol ID
- 2026P001792
- Acronym
- BG2-Aphasia
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Neural data supporting peer-reviewed publications
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia
- ClinicalTrials.gov ID
- NCT07791459
- Acronym / sponsor ID
- BG2-Aphasia / 2026P001792
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Leigh R. Hochberg, MD, PhD.University, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2038 (estimated)
- Study completion
- Dec 2038 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BrainGate Neural Interface System | Experimental | Device: BrainGate Neural Interface SystemDevice: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of expressive aphasia due to ischemic or hemorrhagic stroke (There are additional inclusion criteria)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainGate Neural Interface SystemAlso: BrainGate, NeuroPort, neural prosthesis, neural prostheticUp 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. | Device | BrainGate Neural Interface System |
Primary outcome
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
1 secondary outcome
Feasibility of speech decoding
Time frame: One-year post implant evaluation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. Neural data supporting peer-reviewed publications
Related trials for Expressive Aphasia
Recruiting
Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
Stroke Rehabilitation, Aphasia, Broca
Recruiting
Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia
Aphasia Non Fluent, Stroke
Not yet recruiting
Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity
Non-fluent Aphasia
RecruitingPhase 2
Comparing Traditional Semantic Feature Analysis (tSFA) and Semantic Feature Analysis + Metacognitive Strategy Training (SFA+MST)
Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
Apraxia of Speech, Non-fluent Aphasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leigh R Hochberg, MD, PhD study director
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing BrainGate Neural Interface System in people with Expressive Aphasia and Aphasia Following Cerebral Infarction, run by Leigh R. Hochberg, MD, PhD..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leigh R Hochberg, M.D., Ph.D. (617-726-9247, clinicaltrials@braingate.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the BrainGate2 Neural Interface System (time frame: One year post-implant evaluation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.