An interventional study of BrainGate Neural Interface System in Aphasia, ALS and Stroke, sponsored by Leigh R. Hochberg, MD, PhD.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Leigh R. Hochberg, MD, PhD. · Not applicable, Interventional, and Device feasibility
In this study, the investigators aim to continue the development of a brain-computer interface (BCI) to help restore speech for stroke survivors with agrammatic aphasia, a language disorder that affects the ability to speak.
One in four adults will have a stroke in their lifetime. When the blood flow to the brain is blocked or reduced, brain cells get deprived of oxygen. This might impact language areas in the brain and lead to aphasia.
The goal of this project is to advance the methods by which people with aphasia can help develop and by using an intracortical brain-computer interface (iBCI) restore communication that may serve as a rehabilitation device.
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's planned enrollment of 2 is below the median of 30 across 298 interventional studies indexed under Aphasia.
Browse Aphasia studies →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.
Inclusion Criteria:
Exclusion Criteria:
(There are additional 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.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: BrainGate Neural Interface System
Device: BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) for restoration of speech
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and: 1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period. 2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2031, 60 months later.
Of 183 non-industry interventional studies with no phase under Aphasia, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 60 months is above that.
Counting every sponsor, half of 185 studies reached it within 36 months; a quarter within 20 and three quarters within 57.
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.