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
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.
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.
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 →Leigh R. Hochberg, MD, PhD. is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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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.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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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.
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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.
Also known as: BrainGate, NeuroPort, neural prosthesis, neural prosthetic, neuroprosthetic, brain computer interface, brain-computer interface
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
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
No study locations are listed for this record.
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.
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.
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 ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Leigh R. Hochberg, MD, PhD.