Study Results
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Basic Information
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RECRUITING
NA
5 participants
INTERVENTIONAL
2013-11-01
2027-01-31
Brief Summary
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Development of a brain-machine interface is very difficult and currently only limited technology exists in this area of neuroscience. Other studies have shown that people with high spinal cord injury still have intact brain areas capable of planning movements and grasps, but are not able to execute the movement plans. The device in this study involves implanting very fine recording electrodes into areas of the brain that are known to create arm movement plans and provide hand grasping information and sense feeling in the hand and fingers. These movement and grasp plans would then normally be sent to other regions of the brain to execute the actual movements. By tying into those pathways and sending the movement plan signals to a computer instead, the investigators can translate the movement plans into actual movements by a computer cursor or robotic limb.
A key part of this study is to electrically stimulate the brain by introducing a small amount of electrical current into the electrodes in the sensory area of the brain. This will result in the sensation of touch in the hand and/or fingers. This stimulation to the brain will occur when the robotic limb touches the object, thereby allowing the brain to "feel" what the robotic arm is touching.
The device being used in this study is called the Neuroport Array and is surgically implanted in the brain. This device and the implantation procedure are experimental which means that it has not been approved by the Food and Drug Administration (FDA). One Neuroport Array consists of a small grid of electrodes that will be implanted in brain tissue and a small cable that runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed to be attached to the skull and protrude through the scalp to allow for connection with the computer equipment. The top portion of the pedestal has a protective cover that will be in place when the pedestal is not in use. The top of this pedestal and its protective cover will be visible on the outside of the head. Three Neuroport Arrays and pedestals will be implanted in this study so three of these protective covers will be visible outside of the head. It will be possible to cover these exposed portions of the device with a hat or scarf.
The investigators hope to learn how safe and effective the Neuroport array plus stimulation is in controlling computer generated images and real world objects, such as a robotic arm, using imagined movements of the arms and hands.
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Detailed Description
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We will use the rare opportunity of being able to record from populations of single neurons in a clinical study designed to develop neural prosthetics for tetraplegic participants paralyzed by spinal cord injuries. Cortical implants of microelectrode arrays will be made within three key locations in the sensorimotor system: primary motor cortex, primary somatosensory cortex, and posterior parietal cortex. These microelectrode arrays enable both recording and intracortical microstimulation.
We will test the hypothesis that somatosensory and motor cortex represent imagined reaches in hand coordinates, but posterior parietal cortex is task dependent, and it's population neural activity can flexibly change coordinate frames depending on the effector used in the task. Percepts evoked by intracortical microstimulation and imagined sensations will be used to understand the representation of cutaneous and proprioceptive information within primary somatosensory cortex and posterior parietal cortex. The hypothesis to be tested is that imagined sensation and electrically evoked sensations are highly overlapping - not just in primary somatosensory cortex but also in posterior parietal cortex. Lastly, we hypothesize that the posterior parietal cortex contains in humans an internal model of state estimation that shows plasticity for both natural and brain-control behaviors and transfers this learning to motor cortex.
These studies will not only greatly advance our understanding of the human sensorimotor cortical circuit, but also will provide basic knowledge for the design of future neural prosthetics.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Neural Prosthetic System 2
The Neural Prosthetic System 2 consists of three Neuroport Arrays, which are described in detail in the intervention description. Two of the three Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The third Neuroport Array is inserted into somatosensory cortex, specifically S1 which represents sensory feedback for the hand and fingers. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subject will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought augmented with sensory feedback via intracortical microstimulation. They will then use the end effector to perform various reach and grasp tasks.
Neural Prosthetic System 2 (NPS2)
The NPS2 comprises 3 NeuroPort Arrays (SIROF). The tip of the electrodes are sputtered iridium oxide film (SIROF). Each array is comprised of 100 1.5 mm microelectrodes organized on a 4mm x 4mm silicon base that is 0.25 mm thick. Each microelectrode is insulated with Parylene-C polymer and is electrically isolated from neighboring electrodes by non-conducting glass. Of the 100 electrodes, 96 are wire bonded using 25m gold alloy insulated wires sealed with a silicone elastomer. The wire bundle is potted to a printed circuit board with epoxy, the circuit board is inserted into the Patient Pedestal (percutaneous connector), and then the Patient Pedestal is filled with silicone elastomer. Two fine platinum reference wires are also attached to the Patient Pedestal. The Patient Pedestal is 19 mm wide at the skin interface.
Interventions
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Neural Prosthetic System 2 (NPS2)
The NPS2 comprises 3 NeuroPort Arrays (SIROF). The tip of the electrodes are sputtered iridium oxide film (SIROF). Each array is comprised of 100 1.5 mm microelectrodes organized on a 4mm x 4mm silicon base that is 0.25 mm thick. Each microelectrode is insulated with Parylene-C polymer and is electrically isolated from neighboring electrodes by non-conducting glass. Of the 100 electrodes, 96 are wire bonded using 25m gold alloy insulated wires sealed with a silicone elastomer. The wire bundle is potted to a printed circuit board with epoxy, the circuit board is inserted into the Patient Pedestal (percutaneous connector), and then the Patient Pedestal is filled with silicone elastomer. Two fine platinum reference wires are also attached to the Patient Pedestal. The Patient Pedestal is 19 mm wide at the skin interface.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 22-65
* Able to provide informed consent
* Able to understand and comply with instructions in English
* Communicate via speech
* Surgical clearance
* Life expectancy greater than 12 months
* Travel up to 60 miles to study locations up to five days per week
* Caregiver monitor for surgical site complications and behavioral changes on a daily basis
* Psychosocial support system
Exclusion Criteria
* Intellectual impairment
* Psychotic illness or chronic psychiatric disorder, including major depression if untreated
* Poor visual acuity
* Pregnancy
* Active infection or unexplained fever
* Scalp lesions or skin breakdown
* HIV or AIDS infection
* Active cancer or chemotherapy
* Diabetes
* Autonomic dysreflexia
* History of seizure
* Implanted hydrocephalus shunt
* Previous neurosurgical history affecting parietal lobe function
* Medical conditions contraindicating surgery and chronic implantation of a medical device
* Prior cranioplasty
* Unable to undergo MRI or anticipated need for MRI during study
* Nursing an infant or unwilling to bottle-feed infant
* Chronic oral or intravenous use of steroids or immunosuppressive therapy
* Suicidal ideation
* Drug or alcohol dependence
* Planning to become pregnant, or unwilling to use adequate birth control
* Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.
* Implanted deep brain stimulator (DBS), DBS leads, or cochlear implant.
22 Years
65 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Rancho Los Amigos National Rehabilitation Center
OTHER
University of Colorado, Denver
OTHER
Richard A. Andersen, PhD
OTHER
Responsible Party
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Richard A. Andersen, PhD
James G. Boswell Professor of Neuroscience
Principal Investigators
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Richard A Andersen, PhD
Role: PRINCIPAL_INVESTIGATOR
California Institute of Technology
Charles Liu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California, Rancho Los Amigos Rehabilitation Center
Dan Kramer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Luke Bashford, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
University of Southern California
Los Angeles, California, United States
Richard Andersen
Pasadena, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Charles Liu, MD, PhD
Role: primary
Dan Kramer, MD
Role: primary
References
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Rosenthal IA, Bashford L, Bjanes D, Pejsa K, Lee B, Liu C, Andersen RA. Visual context affects the perceived timing of tactile sensations elicited through intra-cortical microstimulation: a case study of two participants. J Neurophysiol. 2025 Oct 8. doi: 10.1152/jn.00518.2024. Online ahead of print.
Bashford L, Rosenthal IA, Kellis S, Bjanes D, Pejsa K, Brunton BW, Andersen RA. Neural subspaces of imagined movements in parietal cortex remain stable over several years in humans. J Neural Eng. 2024 Aug 28;21(4):046059. doi: 10.1088/1741-2552/ad6e19.
Armenta Salas M, Bashford L, Kellis S, Jafari M, Jo H, Kramer D, Shanfield K, Pejsa K, Lee B, Liu CY, Andersen RA. Proprioceptive and cutaneous sensations in humans elicited by intracortical microstimulation. Elife. 2018 Apr 10;7:e32904. doi: 10.7554/eLife.32904.
Other Identifiers
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HS-13-00492
Identifier Type: -
Identifier Source: org_study_id
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