Downey, California 90242

  • Quadriplegia

Purpose:

This research study is being conducted to develop a brain controlled medical device, called a brain-machine interface. The device will provide people with a spinal cord injury some ability to control an external device such as a computer cursor or robotic limb by using their thoughts along with sensory feedback. 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.


Criteria:

Inclusion Criteria: - High cervical spinal lesion - 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: - Presence of memory problems - 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.


NCT ID:

NCT01964261


Primary Contact:

Principal Investigator
Richard A Andersen, PhD
California Institute of Technology

Charles Liu, MD, PhD
Phone: 800-872-2273
Email: chasliu@cheme.caltech.edu


Backup Contact:

Email: ANDERSEN@VIS.CALTECH.EDU
Richard Andersen, PhD
Phone: 626-395-8336


Location Contact:

Downey, California 90242
United States

Mindy Aisen, MD
Phone: 562-401-8111
Email: maisen@dhs.lacounty.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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