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Trial record 1 of 1 for:    NCT01894802 | spinal cord injury
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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. Identifier: NCT01894802
Recruitment Status : Recruiting
First Posted : July 10, 2013
Last Update Posted : June 30, 2022
University of Chicago
Information provided by (Responsible Party):
Michael Boninger, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Tetraplegia Spinal Cord Injury Brainstem Stroke Brachial Plexus Injury Above Elbow Amputation Device: Implantation of CRS Arrays Not Applicable

Detailed Description:
Individuals with severe paralysis 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."

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Significant Upper Limb Impairment
Actual Study Start Date : December 1, 2013
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects must have limited or no ability to use one or both hands due to cervical spinal cord injury, brainstem stroke, brachial plexus injury, above-elbow amputation, or spinal stroke. Individuals with intact limbs must have less than grade 2 strength in finger flexor and abduction on the contralateral side to the implant and a t-score <35 on the PROMIS Upper Extremity Short Form. The non-functional hand(s) may be involved passively in functional tasks; for example, pushing an object or passively grasping an object placed into the hand. However, the participant must report that they have no functional use of their hand(s).
  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 2 hours 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 2 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.
  14. Participants with transhumeral amputation must have been evaluated for a prosthesis, and if deemed appropriate, were fit with an optimized prosthesis. The prosthesis should be used/considered for the PROMIS evaluation.

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
  27. Individuals who are judged by a clinician as being an unsafe ambulator - This would be decided based on a history of frequent uncontrolled falls more than 3 or 4 in a year, or falls that resulted in injury
  28. Individuals who plan to participate in contact sports or sports that require a helmet

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 identifier (NCT number): NCT01894802

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Contact: Debbie E Harrington 412-383-1355

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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Debbie E Harrington, BS    412-383-1355   
Principal Investigator: Michael L Boninger, MD         
Sponsors and Collaborators
Michael Boninger
University of Chicago
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Principal Investigator: Michael L Boninger, MD University of Pittsburgh
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Michael Boninger, Principal Investigator / Sponsor-Investigator, University of Pittsburgh Identifier: NCT01894802    
Other Study ID Numbers: STUDY19100269
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share de-identified data and study materials with collaborators.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
Keywords provided by Michael Boninger, University of Pittsburgh:
Spinal cord injury
Brainstem or spinal stroke
Brachial plexus injury
Brain-machine interface
Brain-computer interface
Neural activity
Sensory stimulation
Above elbow amputation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Trauma, Nervous System
Brain Stem Infarctions
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Brain Infarction
Brain Ischemia
Pathologic Processes