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Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia

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ClinicalTrials.gov Identifier: NCT01849822
Recruitment Status : Active, not recruiting
First Posted : May 9, 2013
Last Update Posted : July 17, 2018
Sponsor:
Collaborators:
University of Southern California
Rancho Los Amigos National Rehabilitation Center
Information provided by (Responsible Party):
Richard A. Andersen, PhD, California Institute of Technology

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.


Condition or disease Intervention/treatment Phase
Tetraplegia Device: Neural Prosthetic System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : February 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: 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 Name: NeuroPort Array




Primary Outcome Measures :
  1. Patient control over the end effector (virtual or physical) [ Time Frame: One year 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).

  2. Absence of infection or irritation [ Time Frame: One year 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.


Secondary Outcome Measures :
  1. Score on the Action Research Arm Test [ Time Frame: One year after array implantation ]
    The Action Research Arm Test was designed to provide a rapid, reliable test to assess recovery of upper limb function following cortical damage. Three of the four subtests will be scored: grasp, grip and pinch. A four-point scale (0-3) will be used in each of the 16 individual tasks. The total score will be measured and reported.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849822


Locations
United States, California
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
University of Southern California
Los Angeles, California, United States, 90033
California Institute of Technology
Pasadena, California, United States, 91125
Sponsors and Collaborators
Richard A. Andersen, PhD
University of Southern California
Rancho Los Amigos National Rehabilitation Center
Investigators
Principal Investigator: Richard A Andersen, PhD California Institute of Technology
Principal Investigator: Charles Liu, MD, PhD University of Southern California
Principal Investigator: Christi Heck, MD, PhD, MMM University of Southern California
Principal Investigator: Mindy Aisen, MD Rancho Los Amigos National Rehabilitation Center

Additional Information:
Study Data/Documents: Publication  This link exits the ClinicalTrials.gov site
"Hand Shape Representation in Parietal Reach Region". The Journal of Neuroscience.
Publication  This link exits the ClinicalTrials.gov site
"Decoding motor imagery from the posterior parietal cortex of a tetraplegic human." Science

Responsible Party: Richard A. Andersen, PhD, James G. Boswell Professor of Neuroscience, California Institute of Technology
ClinicalTrials.gov Identifier: NCT01849822     History of Changes
Other Study ID Numbers: 16384
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Keywords provided by Richard A. Andersen, PhD, California Institute of Technology:
neural
prosthetic
brain machine interface
brain computer interface
brain control
paralysis
tetraplegia
quadriplegia
spinal cord injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms