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

• ClinicalTrials.gov Identifier: NCT01894802
• Recruitment Status: Recruiting
• First Posted: July 10, 2013
• Last Update Posted: October 14, 2020
• Sponsor: Michael Boninger
• Information provided by (Responsible Party): Michael Boninger, University of Pittsburgh

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.

Condition or disease	Intervention/treatment	Phase
Tetraplegia; Spinal Cord Injury; Brainstem Stroke	Device: Implantation of CRS Arrays	Not Applicable

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 Design

• 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 Tetraplegia
• Study Start Date: December 2013
• Estimated Primary Completion Date: August 2024
• Estimated Study Completion Date: December 2025

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Contacts

Contact: Debbie E Harrington; 412-383-1355; debbie.harrington@pitt.edu

Contact: Casey L Konopisos; 412-648-4035; CLK130@pitt.edu

Locations

United States, Pennsylvania

University of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contact: Debbie E Harrington, BS 412-383-1355 debbie.harrington@pitt.edu

Contact: Casey Konopisos 412-648-4035 CLK130@pitt.edu

Principal Investigator: Michael L Boninger, MD

Sponsors and Collaborators

Michael Boninger

Investigators

• Principal Investigator: Michael L Boninger, MD; University of Pittsburgh

More Information

Additional Information:

University of Pittsburgh Medical Center / Brain-Computer Interface Media Page 

Human Rehabilitation and Neural Engineering Laboratory 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

• Responsible Party: Michael Boninger, Principal Investigator / Sponsor-Investigator, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01894802
• Other Study ID Numbers: STUDY19100269
• First Posted: July 10, 2013
• Last Update Posted: October 14, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: We may 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:

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:

Spinal Cord Injuries; Quadriplegia; Brain Stem Infarctions; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Brain Infarction; Brain Ischemia