Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia
NCT ID: NCT01849822
Last Updated: 2021-04-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1 participants
INTERVENTIONAL
2013-02-28
2019-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Developing a brain-machine interface (BMI) is very difficult and currently only limited technology exists in this area of neuroscience. 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. 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.
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 with 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 though the scalp to allow for connection with the computer equipment.
The investigators hope to learn how safe and effective the NeuroPort Array is in controlling computer generated images and real world objects, such as a robotic arm, using imagined movements of the arms and hands. To accomplish this goal, two NeuroPort Arrays will be used.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sensory Motor Transformations in Human Cortex
NCT01964261
Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
NCT02550522
Reanimation in Tetraplegia
NCT01997125
Biofeedback for Wheelchair Users
NCT02700178
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
NCT05035823
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Neural Prosthetic System
The Neural Prosthetic System consists of two Neuroport Arrays, which are described in detail in the intervention description. Both Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subjects will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought. They will then use the end effector to perform various reach and grasp tasks.
Neural Prosthetic System
The Neural Prosthetic System is primarily composed of two NeuroPort Arrays. Each array is comprised of 100 microelectrodes (1.5 mm in length) uniformly organized on a 4 mm x 4 mm 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. Each microelectrode has a platinum tip that is 100-200 microns in length and offers impedance values from 100-800 kilo-ohms. Of the 100 electrodes, 96 are wire bonded using 25 micron gold alloy insulated wires collectively sealed with a silicone elastomer. The wire bundle is potted to a printed circuit board with epoxy, the printed 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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Neural Prosthetic System
The Neural Prosthetic System is primarily composed of two NeuroPort Arrays. Each array is comprised of 100 microelectrodes (1.5 mm in length) uniformly organized on a 4 mm x 4 mm 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. Each microelectrode has a platinum tip that is 100-200 microns in length and offers impedance values from 100-800 kilo-ohms. Of the 100 electrodes, 96 are wire bonded using 25 micron gold alloy insulated wires collectively sealed with a silicone elastomer. The wire bundle is potted to a printed circuit board with epoxy, the printed 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
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to provide informed consent
* Able to understand and comply with instructions in English
* Able to communicate via speech
* Surgical clearance
* Life expectancy greater than 12 months
* Live within 60 miles of study location and willing to travel up to 5 days per week
* A regular caregiver to monitor the surgical site
* Psychosocial support system
Exclusion Criteria
* intellectual impairment
* Psychotic illness or chronic psychiatric disorder, including major depression
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Southern California
OTHER
Rancho Los Amigos National Rehabilitation Center
OTHER
Richard A. Andersen, PhD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Richard A. Andersen, PhD
James G. Boswell Professor of Neuroscience
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard A Andersen, PhD
Role: PRINCIPAL_INVESTIGATOR
California Institute of Technology
Charles Liu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Christi Heck, MD, PhD, MMM
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Mindy Aisen, MD
Role: PRINCIPAL_INVESTIGATOR
Rancho Los Amigos National Rehabilitation Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
University of Southern California
Los Angeles, California, United States
California Institute of Technology
Pasadena, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Saif-Ur-Rehman M, Lienkamper R, Parpaley Y, Wellmer J, Liu C, Lee B, Kellis S, Andersen R, Iossifidis I, Glasmachers T, Klaes C. SpikeDeeptector: a deep-learning based method for detection of neural spiking activity. J Neural Eng. 2019 Jul 23;16(5):056003. doi: 10.1088/1741-2552/ab1e63.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Publication
"Hand Shape Representation in Parietal Reach Region". The Journal of Neuroscience.
View DocumentDocument Type: Publication
"Decoding motor imagery from the posterior parietal cortex of a tetraplegic human." Science
View DocumentRelated Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16384
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.