Cortical Recording and Stimulating Array Brain-Machine Interface (CRS Array BMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Pittsburgh
Sponsor:
Collaborators:
Defense Advanced Research Projects Agency
Johns Hopkins University
Information provided by (Responsible Party):
Michael Boninger, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01894802
First received: July 3, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The purpose of this research study is to demonstrate the safety and efficacy of using two CRS Arrays (microelectrodes) for long-term recording of brain motor cortex activity and microstimulation of brain sensory cortex.


Condition Intervention
Tetraplegia
Spinal Cord Injury
Brainstem Stroke
Device: Implantation of CRS Arrays in the motor cortex and sensory cortex of the brain

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The primary outcome is the safety of the participant. [ Time Frame: One year following array implantation ] [ Designated as safety issue: Yes ]
    This measure will be considered a success if the device is not removed for safety reasons during the 12-month post-implant evaluation.


Secondary Outcome Measures:
  • The secondary outcome is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices. [ Time Frame: One year following array implantation ] [ Designated as safety issue: No ]
    The efficacy of the CRS Arrays will be determined through a variety of measures, including characterization of signal quality, degrees of freedom achieved and subject performance.


Estimated Enrollment: 5
Study Start Date: December 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brain-Machine Interface Users
All participants enrolled in the study who meet eligibility criteria will be individuals implanted with microelectrodes in their brain to record neural activity. There is no control group.
Device: Implantation of CRS Arrays in the motor cortex and sensory cortex of the brain
Two Blackrock Microsystems CRS Arrays will be implanted in the motor cortex and sensory cortex of study participants.
Other Names:
  • neuroprosthetic
  • brain-machine interface
  • brain-computer interface
  • microelectrode
  • array

Detailed Description:

Individuals with tetraplegia (paralysis caused by illness or injury that results in partial or total loss of the use of the arms and legs) have intact brain function but are unable to move due to injury or disease affecting the spinal cord, nerves or muscles. Brain-machine interface (BMI) technology is based on the finding that with intact brain function, neural (nerve) signals are generated even though they do not reach the arms, hands and legs. By placing (implanting) sensors on the surface of the brain, individuals can be trained to send neural signals which are interpreted by a computer and translated to movement which can then be used to control a variety of devices or computer displays. Using neural activity to control an external device is referred to as a brain-machine interface (BMI) technology. In addition, areas of the brain that are involved in interpreting sensations from the arms, hands and legs remain functional after injury. It is therefore possible to send tiny electrical pulses through implanted arrays to mimic sensory input that would normally come from the arms, hands and legs. The investigators refer to this as "microstimulation."

  Eligibility

Ages Eligible for Study:   22 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have limited or no ability to use both hands due to cervical spinal cord injury, brainstem stroke or spinal stroke. Individuals with tetraplegia must have less than grade 4 muscle strength in elbow extension and wrist extension and less than grade 2 strength in finger flexor and abduction on the contralateral side to the implant. We will include subjects with both complete and incomplete injuries.
  2. Subjects must report that they are unable to perform functional activities with the hand contralateral to implantation.
  3. Subjects must be over 1 year post-injury at time of implantation. In addition, subject must report no worsening in neurologic status (strength, sensation) for the previous 6 months.
  4. Subjects must be between the ages of 22-70 years old. Participants outside this age range may be at an increased surgical risk and increased risk of fatigue during BMI training.
  5. Subjects must live within 1 hour of the University of Pittsburgh during the study or be willing to travel to the University of Pittsburgh at least once per week for BMI training.
  6. If subjects do not live in the Pittsburgh area, they are expected to stay somewhere within 1 hour of the University of Pittsburgh for at least 18 months after enrollment.
  7. Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.
  8. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators
  9. Subjects must have results that are within normal limits on neuropsychological and psychosocial assessment; psychosocial health and support will be assessed by interview with the psychologist.
  10. Subjects must be able to activate distinct cortical areas during imagined or attempted movement tasks (i.e. hand movement and speaking or moving the mouth); this will be evaluated with functional magnetic resonance imaging (fMRI) as part of screening.
  11. Subjects must have a stable psychosocial support and caregivers who are able to perform the necessary daily care of the participant's skin and pedestal site. This requires that the subject identify a caregiver and a backup who have been in place for greater than 6 months and are able to provide needed physical and psychosocial support. This will be assessed by the sponsor-investigator and study neurosurgeon.
  12. Subjects must have a life expectancy greater than 18 months as assessed by the study investigator and neurosurgeon sub-investigator
  13. Documentation of informed consent must be obtained from the participant or their legal representative.

Exclusion Criteria:

  1. Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
  2. Another serious disease(s) or disorder(s) that could affect ability to participate in this study (verified during pre-op anesthesia evaluation to determine surgical risk status)
  3. Recent history of pressure sores that could be exacerbated by 1-2 days of bed rest
  4. Metallic implant(s) that would prohibit the subject from having an fMRI scan; spinal fixators are generally non-ferrous and would not exclude someone from participating in the study
  5. Any type of implantable generator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator (DBS), DBS leads, vagus nerve stimulator, or defibrillator
  6. Women of childbearing age who are pregnant, lactating, or plan to become pregnant during the next 25 months
  7. Allergy to contrast medium or kidney failure that could be exacerbated by contrast agent (for MRI)
  8. Subjects receiving medications (such as sedatives) chronically that may retard motor coordination and cognitive ability
  9. Individuals who require routine MRI, therapeutic ultrasound, or diathermy
  10. Individuals with osteomyelitis
  11. Severe skin disorder that causes excessive skin sloughing, lesions or breakdown of the scalp
  12. History of myocardial infarction or cardiac arrest or with intractable cardiac arrhythmias
  13. Individuals with an implanted hydrocephalus shunt
  14. Individuals who have had a stroke caused by a surgical procedure
  15. Active infection(s) or unexplained fever (verified during pre-op anesthesia evaluation to determine surgical risk status)
  16. Consumption of more than 1 alcoholic beverage per day on average
  17. Receiving chronic oral or intravenous steroids or immunosuppressive therapy
  18. Active cancer within the past year (other than adequately treated basal cell or squamous cell skin cancer) or require chemotherapy
  19. Uncontrolled insulin dependent diabetes mellitus
  20. Uncontrolled autonomic dysreflexia within the past 3 months (for those with spinal cord injury)
  21. Individuals with seizure disorders currently being treated with anti-epileptic medications and individuals with a familial history of seizure disorders
  22. Individuals who have attempted suicide in the past 12 months
  23. Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise (including, but not limited to: ataxia-telangiectasia, cancer, Chediak-Higashi syndrome, combined immunodeficiency disease, complement deficiencies, DiGeorge syndrome, HIV/AIDS, hypogammaglobulinemia, Job syndrome, leukocyte adhesion defects, malnutrition, panhypogammaglobulinemia, Bruton disease, congenital agammaglobulinemia, selective deficiency of IgA and Wiscott-Aldrich syndrome)
  24. Individuals who have had previous neurosurgical intervention involving the frontal lobes (especially the motor cortex) and/or parietal lobe (especially the somatosensory cortex) that is likely to impact the viability of an intracortical electrode
  25. Individuals with active psychiatric concerns, including but not limited to major depression, bipolar disorder, schizophrenia or other psychotic disorder and post-traumatic stress disorder
  26. Individuals with substance abuse within 6 months of study participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894802

Contacts
Contact: Debbie E Harrington, BS 412-383-1355 harringtond2@upmc.edu
Contact: Holly A Jourdan, MA 412-383-1043 jourdanha@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Debbie E Harrington, BS    412-383-1355    harringtond2@upmc.edu   
Contact: Holly A Jourdan, MA    412-383-1043    jourdanha@upmc.edu   
Principal Investigator: Michael L Boninger, MD         
Sponsors and Collaborators
University of Pittsburgh
Defense Advanced Research Projects Agency
Johns Hopkins University
Investigators
Principal Investigator: Michael L Boninger, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Boninger, Principal Investigator / Sponsor-Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01894802     History of Changes
Other Study ID Numbers: PRO12100092
Study First Received: July 3, 2013
Last Updated: April 10, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Tetraplegia
Quadriplegia
Spinal cord injury
Brainstem or spinal stroke
Neuroprosthetic
Brain-machine interface
Brain-computer interface
Neural activity
Sensory stimulation
Microstimulation

Additional relevant MeSH terms:
Quadriplegia
Spinal Cord Injuries
Stroke
Brain Stem Infarctions
Wounds and Injuries
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Cerebrovascular Disorders
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 21, 2014