Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01894802
Recruitment Status : Recruiting
First Posted : July 10, 2013
Last Update Posted : February 23, 2021
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
Michael Boninger, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE July 3, 2013
First Posted Date  ICMJE July 10, 2013
Last Update Posted Date February 23, 2021
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
The primary outcome is the safety of the participant. [ Time Frame: One year following array implantation ]
This measure will be considered a success if the device is not removed for safety reasons during the 12-month post-implant evaluation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
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 ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cortical Recording and Stimulating Array Brain-Machine Interface
Official Title  ICMJE A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Tetraplegia
Brief Summary 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.
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."
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Tetraplegia
  • Spinal Cord Injury
  • Brainstem Stroke
Intervention  ICMJE Device: Implantation of CRS Arrays
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
Study Arms  ICMJE 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.
Intervention: Device: Implantation of CRS Arrays
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2013)
5
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Debbie E Harrington 412-383-1355 debbie.harrington@pitt.edu
Contact: Casey L Konopisos 412-648-4035 CLK130@pitt.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01894802
Other Study ID Numbers  ICMJE STUDY19100269
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We will share de-identified data and study materials with collaborators.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Information will be shared throughout duration of collaboration.
Access Criteria: Collaborators will receive data and study materials to assist with duplicating our efforts remotely.
Responsible Party Michael Boninger, University of Pittsburgh
Study Sponsor  ICMJE Michael Boninger
Collaborators  ICMJE University of Chicago
Investigators  ICMJE
Principal Investigator: Michael L Boninger, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP