An interventional study of Placement of the BrainGate2 sensor(s) into the motor-related cortex in Tetraplegia, Spinal Cord Injuries and Amyotrophic Lateral Sclerosis, sponsored by Leigh R. Hochberg, MD, PhD.. Recruiting at 6 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-01.
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.
20 studies on the registry are indexed under Locked-In Syndrome; 12 are open to participants now.
This study's planned enrollment of 27 is above the median of 7 across 17 interventional studies indexed under Locked-In Syndrome.
Browse Locked-In Syndrome studies →Leigh R. Hochberg, MD, PhD. is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Compared within Locked-In Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Quadriplegia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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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.
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.
BrainGate Neural Interface System
Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex
Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of 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
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
To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints.
Time frame: Course of the study
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Leigh R. Hochberg, MD, PhD.