An interventional study of BrainGate Neural Interface System in Anarthria, Dysarthria and Tetraplegia, sponsored by Leigh R. Hochberg, MD, PhD.. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Leigh R. Hochberg, MD, PhD. · Not applicable, Interventional, and Other
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
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, to recover a host of abilities that normally rely on the hands or on speech.
60 studies on the registry are indexed under Dysarthria; 19 are open to participants now.
This study's planned enrollment of 3 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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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.
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
Device Safety
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
Device Feasibility
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: Number of participants that are able to use the BrainGate system to communicate via speech decoding: 1. at a rate of at least 5 words per minute and 2. with less than a median word error rate of 50%.
Time frame: At participant exit from study, or up to 5 years
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Leigh R. Hochberg, MD, PhD.