ClinicalTrials.gg
Not yet recruitingNCT07791459BG2-Aphasia-01Updated Nov 6, 2026

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)

An interventional study of BrainGate Neural Interface System in Expressive Aphasia, Aphasia Following Cerebral Infarction and Aphasia Following Nontraumatic Intracerebral Hemorrhage, sponsored by Leigh R. Hochberg, MD, PhD.. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Leigh R. Hochberg, MD, PhD. · Not applicable, Interventional, and Device feasibility

Updated Nov 6, 2026Title changedStart date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Aphasia, Broca

35 studies on the registry are indexed under Aphasia, Broca; 11 are open to participants now.

This study's planned enrollment of 5 is below the median of 36 across 33 interventional studies indexed under Aphasia, Broca.

Browse Aphasia, Broca studies →

Lead sponsor

Leigh R. Hochberg, MD, PhD. is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of expressive aphasia due to ischemic or hemorrhagic stroke (There are additional inclusion criteria)

Exclusion 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 or therapy
  • Other serious disease or disorder that could seriously affect ability to participate in the study (There are additional exclusion criteria)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceBrainGate 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.

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

06

What researchers measure

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

    Time frame: 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.

    Time frame: One-year post implant evaluation period

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Neural data supporting peer-reviewed publications

Supporting information: Analytic code

Time frame: At the time of peer review

Access criteria: Public server

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Sep 2038, 142 months later.

Of 18 interventional studies with no phase under Aphasia, Broca, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 57. This study's planned 142 months is above that.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Nov 2026, on Oct 22, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Aug 28, 2026
StartEst.
Nov 2026was Aug 2026
Primary completionEst.
Sep 2038
CompletionEst.
Dec 2038
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Aug 2026→Nov 2026
Oct 22, 2026
Title
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Nov 6, 2026
Show all 2 updates
  1. Nov 6, 2026
    Title BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
    + 1 other change: verification date
  2. Oct 22, 2026
    Start date Aug 2026→Nov 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07791459
Lead sponsor
Leigh R. Hochberg, MD, PhD.
Responsible party
Leigh R. Hochberg, MD, PhD. (Sponsor-Investigator, Massachusetts General Hospital) — Sponsor-investigator
First posted
Aug 28, 2026
Start date
Nov 2026 (estimated)
Primary completion
Sep 2038 (estimated)
Completion
Dec 2038 (estimated)
Last update
Nov 6, 2026

Study contacts

Leigh R Hochberg, M.D., Ph.D.
Contact
clinicaltrials@braingate.org
617-726-9247
Maryam Masood, M.S.
Contact
clinicaltrials@braingate.org
617-726-2241
Leigh R Hochberg, MD, PhD
study director · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion