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The purpose of this research study is to demonstrate that individuals with upper limb paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis and brain stem stroke can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain computer interface system.
Brain-computer interface (BCI) technology aims to establish a direct link for transmitting information between the brain and external devices, offering a natural and rich control signal for prosthetic hands or functional electrical stimulators (FES) to re-animate paralyzed hands. This study focuses on an ECoG-based BCI system. ECoG measures brain activity using electrodes implanted on the surface of the brain. Each participant will undergo testing of the ECoG direct brain interface for up to 29 days. Participants will learn to control computer cursors, virtual reality environments, and assistive devices such as hand orthoses and functional electrical stimulators using neural activity recorded with the ECoG sensor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Brain Interface Users | Experimental | All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of ECoG sensors on the brain surface | Device | One ECoG sensor will be implanted over the motor cortex of study participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG | Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG. | Up to 29 days of device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System | Participants will be asked to perform, attempt, or imagine performing motor tasks while their brain activity is recorded in order to observe the changes in neural activity during each task. | Up to 29 days of device implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Collinger, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29160240 | Derived | Degenhart AD, Hiremath SV, Yang Y, Foldes S, Collinger JL, Boninger M, Tyler-Kabara EC, Wang W. Remapping cortical modulation for electrocorticographic brain-computer interfaces: a somatotopy-based approach in individuals with upper-limb paralysis. J Neural Eng. 2018 Apr;15(2):026021. doi: 10.1088/1741-2552/aa9bfb. |
| Label | URL |
|---|---|
| Brain Computer Interface Research at University of Pittsburgh Medical Center (UPMC) / University of Pittsburgh | View source |
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Study sponsors, as well as the FDA, will have access to research data and documents in order to monitor the integrity of the study.
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This study did not include "arms" or group assignments.
Recruitment included interfacing with local research registry participants, clinical SCI physicians, MDS and ALS groups, and attending conferences attended by eligibility populations
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| ID | Title | Description |
|---|---|---|
| FG000 | Direct Brain Interface Users | All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms. Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All individuals were English speaking, with a disability of at least one hand/arm, but no other health issues which would interfere with or be made worse by study participation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Direct Brain Interface Users | All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms. Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG | Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG. | Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease. | Posted | Number | participants | Up to 29 days of device implantation |
|
6 months
The period of enrollment for participants who completed the study approximately 6 months. This included up to 3 months of screening visits, 1 month of testing during implantation, and up to 2 months of follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Direct Brain Interface Users | All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms. Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neck pain following implant surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant's neck was sore for a few days following implant surgery. This type of pain as described in the consent form. Pain subsided after a few days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Collinger | University of Pittsburgh | 412-383-1274 | collingr@pitt.edu |
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| D013119 | Spinal Cord Injuries |
| D009136 | Muscular Dystrophies |
| D020526 | Brain Stem Infarctions |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D062207 | Brain-Computer Interfaces |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System | Participants will be asked to perform, attempt, or imagine performing motor tasks while their brain activity is recorded in order to observe the changes in neural activity during each task. | Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease. | Posted | Number | participants | Up to 29 days of device implantation |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| 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 |