ALS, Brachial Plexus Injury, Brainstem Stroke, Muscular Dystrophy, Spinal Cord Injury, Tetraplegia
Conditions
Keywords
Electrocorticography, Tetraplegia, Spinal cord injury, Brainstem stroke, Neuroprosthetic, Brain-computer interface, Direct brain interface, Neural activity, Motor cortex
Brief summary
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.
Detailed description
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.
Interventions
DEVICEImplantation of ECoG sensors on the brain surface
One ECoG sensor will be implanted over the motor cortex of study participants
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Limited or no ability to use both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, or amyotrophic lateral sclerosis (ALS) or other motor neuron diseases * At least 1 year post-injury * Live within 1 hour of the University of Pittsburgh or willing to stay in Pittsburgh while the ECoG electrode is implanted (up to 29 days) * Additional inclusion criteria must also be reviewed
Exclusion criteria
* Certain implanted devices * Presence of other serious disease or disorder that could affect ability to participate in this study * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG | Up to 29 days of device implantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System | Up to 29 days of device implantation | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment included interfacing with local research registry participants, clinical SCI physicians, MDS and ALS groups, and attending conferences attended by eligibility populations
Pre-assignment details
This study did not include arms or group assignments.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Determined ineligible during screening. | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Direct Brain Interface Users |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 39 years |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: Up to 29 days of device implantation
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Direct Brain Interface Users | Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG | 3 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.
Time frame: Up to 29 days of device implantation
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Direct Brain Interface Users | Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System | 3 participants |