An interventional study of BrainGate Neural Interface System in Anarthria, Dysarthria and Tetraplegia, sponsored by Leigh R. Hochberg, MD, PhD.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by Leigh R. Hochberg, MD, PhD. · Not applicable, Interventional, and Other
The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.
The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interface". The implanted medical device measures the person's brain activity as they try to talk and outputs their intended speech. By bypassing the injured parts of the nervous system this way, we can observe how individual brain cells are involved in speaking and working together as a network, to produce speech, and we can learn to decipher this activity to output what the person is trying to say.
60 studies on the registry are indexed under Dysarthria; 19 are open to participants now.
This study's planned enrollment of 2 is below the median of 39 across 44 interventional studies indexed under Dysarthria.
Browse Dysarthria 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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(There are additional 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.
Placement of the BrainGate2 sensor(s) into the speech-related cortex
Device: BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into the speech-related cortex
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
Decoded speech output accuracy
The purpose of this feasibility measure is to define the metrics by which a larger trial of intracortical recording for the restoration of speech-based communication might be planned. The secondary endpoints are: * The word error rate of speech that is output by the System * The phoneme error rate of speech that is output by the System
Time frame: At participant exit from study, or up to 5 years
Started Oct 2023 (actual). Primary completion is estimated for Aug 2027, 46 months after the start.
Of 34 interventional studies with no phase under Dysarthria, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 46 months is above that.
How these figures are worked out, and which studies are left out of them.
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Leigh R. Hochberg, MD, PhD.