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| ID | Type | Description | Link |
|---|---|---|---|
| 1DP2DC021055 | 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BrainGate Neural Interface System | Experimental | 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 |
|---|---|---|
| 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 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| At participant exit from study, or up to 5 years |
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Inclusion Criteria:
(There are additional inclusion criteria)
Exclusion Criteria:
(There are additional exclusion criteria)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leigh R. Hochberg, M.D., Ph.D. | Contact | 617-724-9247 | lhochberg@mgh.harvard.edu | |
| Sergey Stavisky, Ph.D. | Contact | 530-754-3413 | sstavisky@ucdavis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sergey Stavisky, Ph.D. | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Recruiting | Sacramento | California | 95817 | United States |
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| 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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