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

Primary Purpose

Tetraplegia, Spinal Cord Injury, Brainstem Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implantation of CRS Arrays
Sponsored by
Michael Boninger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tetraplegia focused on measuring Tetraplegia, Quadriplegia, Spinal cord injury, Brainstem or spinal stroke, Neuroprosthetic, Brain-machine interface, Brain-computer interface, Neural activity, Sensory stimulation, Microstimulation, Brachial plexus injury, Above elbow amputation

Eligibility Criteria

22 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain-Machine Interface Users

Arm Description

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.

Outcomes

Primary Outcome Measures

The primary outcome is the safety of the participant.
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.
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.

Full Information

First Posted
July 3, 2013
Last Updated
March 3, 2023
Sponsor
Michael Boninger
Collaborators
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01894802
Brief Title
Cortical Recording and Stimulating Array Brain-Machine Interface
Acronym
CRS-BMI
Official Title
A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Significant Upper Limb Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2013 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Boninger
Collaborators
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia, Spinal Cord Injury, Brainstem Stroke, Brachial Plexus Injury, Above Elbow Amputation
Keywords
Tetraplegia, Quadriplegia, Spinal cord injury, Brainstem or spinal stroke, Neuroprosthetic, Brain-machine interface, Brain-computer interface, Neural activity, Sensory stimulation, Microstimulation, Brachial plexus injury, Above elbow amputation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain-Machine Interface Users
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Implantation of CRS Arrays
Other Intervention Name(s)
neuroprosthetic, brain-machine interface, brain-computer interface, microelectrode, array
Intervention Description
Two Blackrock Microsystems CRS Arrays will be implanted in the motor cortex and sensory cortex of study participants.
Primary Outcome Measure Information:
Title
The primary outcome is the safety of the participant.
Description
This measure will be considered a success if the device is not removed for safety reasons during the 12-month post-implant evaluation.
Time Frame
One year following array implantation
Secondary Outcome Measure Information:
Title
The secondary outcome is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices.
Description
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.
Time Frame
One year following array implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Subjects must report that they are unable to perform functional activities with the hand contralateral to implantation. 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. 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. 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. 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. Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators 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. 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. 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. Subjects must have a life expectancy greater than 18 months as assessed by the study investigator and neurosurgeon sub-investigator Documentation of informed consent must be obtained from the participant or their legal representative. 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: Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses 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) Recent history of pressure sores that could be exacerbated by 1-2 days of bed rest 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 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 Women of childbearing age who are pregnant, lactating, or plan to become pregnant during the next 25 months Allergy to contrast medium or kidney failure that could be exacerbated by contrast agent (for MRI) Subjects receiving medications (such as sedatives) chronically that may retard motor coordination and cognitive ability Individuals who require routine MRI, therapeutic ultrasound, or diathermy Individuals with osteomyelitis Severe skin disorder that causes excessive skin sloughing, lesions or breakdown of the scalp History of myocardial infarction or cardiac arrest or with intractable cardiac arrhythmias Individuals with an implanted hydrocephalus shunt Individuals who have had a stroke caused by a surgical procedure Active infection(s) or unexplained fever (verified during pre-op anesthesia evaluation to determine surgical risk status) Consumption of more than 1 alcoholic beverage per day on average Receiving chronic oral or intravenous steroids or immunosuppressive therapy Active cancer within the past year (other than adequately treated basal cell or squamous cell skin cancer) or require chemotherapy Uncontrolled insulin dependent diabetes mellitus Uncontrolled autonomic dysreflexia within the past 3 months (for those with spinal cord injury) Individuals with seizure disorders currently being treated with anti-epileptic medications and individuals with a familial history of seizure disorders Individuals who have attempted suicide in the past 12 months 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) 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 Individuals with active psychiatric concerns, including but not limited to major depression, bipolar disorder, schizophrenia or other psychotic disorder and post-traumatic stress disorder Individuals with substance abuse within 6 months of study participation 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 Individuals who plan to participate in contact sports or sports that require a helmet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia L Aumiller
Phone
412-648-4192
Email
OLA22@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Debbie Harrington
Phone
412-383-1355
Email
debbie.harrington@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Boninger, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbie E Harrington, BS
Phone
412-383-1355
Email
debbie.harrington@pitt.edu
First Name & Middle Initial & Last Name & Degree
Michael L Boninger, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share de-identified data and study materials with collaborators.
IPD Sharing Time Frame
Information will be shared throughout duration of collaboration.
IPD Sharing Access Criteria
Collaborators will receive data and study materials to assist with duplicating our efforts remotely.
Citations:
PubMed Identifier
34847547
Citation
Sponheim C, Papadourakis V, Collinger JL, Downey J, Weiss J, Pentousi L, Elliott K, Hatsopoulos NG. Longevity and reliability of chronic unit recordings using the Utah, intracortical multi-electrode arrays. J Neural Eng. 2021 Dec 28;18(6):10.1088/1741-2552/ac3eaf. doi: 10.1088/1741-2552/ac3eaf.
Results Reference
derived
PubMed Identifier
32494819
Citation
Downey JE, Quick KM, Schwed N, Weiss JM, Wittenberg GF, Boninger ML, Collinger JL. The Motor Cortex Has Independent Representations for Ipsilateral and Contralateral Arm Movements But Correlated Representations for Grasping. Cereb Cortex. 2020 Sep 3;30(10):5400-5409. doi: 10.1093/cercor/bhaa120.
Results Reference
derived
PubMed Identifier
30429772
Citation
Downey JE, Weiss JM, Flesher SN, Thumser ZC, Marasco PD, Boninger ML, Gaunt RA, Collinger JL. Implicit Grasp Force Representation in Human Motor Cortical Recordings. Front Neurosci. 2018 Oct 31;12:801. doi: 10.3389/fnins.2018.00801. eCollection 2018.
Results Reference
derived
PubMed Identifier
29553484
Citation
Downey JE, Schwed N, Chase SM, Schwartz AB, Collinger JL. Intracortical recording stability in human brain-computer interface users. J Neural Eng. 2018 Aug;15(4):046016. doi: 10.1088/1741-2552/aab7a0. Epub 2018 Mar 19.
Results Reference
derived
PubMed Identifier
29209023
Citation
Downey JE, Brane L, Gaunt RA, Tyler-Kabara EC, Boninger ML, Collinger JL. Motor cortical activity changes during neuroprosthetic-controlled object interaction. Sci Rep. 2017 Dec 5;7(1):16947. doi: 10.1038/s41598-017-17222-3.
Results Reference
derived
PubMed Identifier
26987662
Citation
Downey JE, Weiss JM, Muelling K, Venkatraman A, Valois JS, Hebert M, Bagnell JA, Schwartz AB, Collinger JL. Blending of brain-machine interface and vision-guided autonomous robotics improves neuroprosthetic arm performance during grasping. J Neuroeng Rehabil. 2016 Mar 18;13:28. doi: 10.1186/s12984-016-0134-9.
Results Reference
derived
Links:
URL
http://upmc.com/bci
Description
University of Pittsburgh Medical Center / Brain-Computer Interface Media Page
URL
http://rnel.pitt.edu/
Description
Rehabilitation and Neural Engineering Laboratory

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Cortical Recording and Stimulating Array Brain-Machine Interface

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