A Feasibility Study of the Ability of the Neural Prosthetic System to Provide Direct Brain Control of Extracorporeal Devices in Patients With Quadriplegia Due to High Spinal Cord Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tetraplegia
- Sponsor
- Richard A. Andersen, PhD
- Enrollment
- 1
- Locations
- 3
- Primary Endpoint
- Number of Participants With Patient Control Over the End Effector (Virtual or Physical)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Richard A. Andersen, PhD
James G. Boswell Professor of Neuroscience
California Institute of Technology
Eligibility Criteria
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
- •Autonomic dysreflexia
Outcomes
Primary Outcomes
Number of Participants With Patient Control Over the End Effector (Virtual or Physical)
Time Frame: Six years after array implantation
The primary effectiveness objective of this study is to evaluate the effectiveness of the NPS in controlling virtual or physical end effectors. The driving hypotheses are that control over the physical and virtual end effectors, as measured by accuracy, will be significantly greater than the level of chance. Three methods will be used to assess the effectiveness of the extracorporeal device: standardized tests, comparison of task performance to the level of chance, and the Quality-of-Life Inventory (QOLI). In collaboration with therapists at Rancho Los Amigos National Rehabilitation Center, two commonly-used, standard tests have been selected by which the use of robotic arm will be evaluated: the Action Research Arm Test (ARAT) and the Canadian Occupational Performance Measure (COPM).
Number of Participants With Absence of Infection or Irritation
Time Frame: Six years after array implantation
The primary objective of this study is to evaluate the safety of the NPS. The driving hypotheses are that the implantation will not be associated with infection or irritation, and that the serious adverse event rate will not rise above 1%. The method of evaluation will be inspection of subject's scalp for evidence of reddening or discharge; review of new symptoms including possible fever, headache, visual or auditory changes, or change in mood or behavior; serial neurologic exams. The condition of the area will be compared with its condition on previous visits. History will be obtained regarding new symptoms. Neurologic exam will be compared to baseline neuro exam. The SAE rate will be calculated as the number of SAEs per implant days.