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| ID | Type | Description | Link |
|---|---|---|---|
| U01DC019430 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BrainGate Neural Interface System | Other | Placement of the BrainGate2 sensor(s) into the speech-related cortex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BrainGate Neural Interface System | Device | Placement of the BrainGate2 sensor(s) into the speech-related cortex |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
(There are additional exclusion criteria)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leigh R Hochberg, MD, Ph.D | Contact | 617-724-9247 | lhochberg@mgh.harvard.edu | |
| Jaimie Henderson, MD | Contact | 650-723-5574 | henderj@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jaimie Henderson, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Recruiting | Stanford | California | 94305 | United States |
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| At participant exit from study, or up to 5 years |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| ID | Term |
|---|---|
| D004401 | Dysarthria |
| D011782 | Quadriplegia |
| D013119 | Spinal Cord Injuries |
| D000690 | Amyotrophic Lateral Sclerosis |
| D020526 | Brain Stem Infarctions |
| D000080422 | Locked-In Syndrome |
| D009136 | Muscular Dystrophies |
| ID | Term |
|---|---|
| D001184 | Articulation Disorders |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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