Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia

Richard A. Andersen, PhD

Status: Completed

Conditions: Tetraplegia

Treatments: Device: Neural Prosthetic System

Study type: Interventional

Funder types: Other

Identifiers

NCT01849822

16384 (Other Identifier)

Details and patient eligibility

About

This research study is being done to develop a brain controlled medical device, called a brain-machine interface or BMI, that 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.

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• High cervical spinal lesion
• 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

• Presence of memory problems
• 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Neural Prosthetic System

Experimental group

Description:

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.

Treatment:

Device: Neural Prosthetic System