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TetraplegiaCRS-BMINCT01894802

Cortical Recording and Stimulating Array Brain-Machine Interface

A study testing Implantation of CRS Arrays in people with Tetraplegia and Spinal Cord Injury, run by Michael Boninger at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 22 to 70 years
Conditions the study is for
Tetraplegia, Spinal Cord Injury, Brainstem Stroke
What is being tested?
Implantation of CRS Arrays
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
1 Dec 2013to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 at the time of enrollment and completion of the study. 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 research site during the study or be willing to travel to the research site at least once per week for BMI training.
  • If subjects do not live in the area, they are expected to stay somewhere within 2 hours of the research site for at least 18 months after enrollment.
Show all 14Show fewer
  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Olivia L Campbell contact

412-648-4192

OLA22@pitt.edu

Debbie Harrington contact

412-383-1355

debbie.harrington@pitt.edu

United States2 sites, 2 recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Ashley van Driesche, BS, 773-834-5204, ashleyv@uchicago.edu

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

    Debbie E Harrington, BS, 4123831355, debbie.harrington@pitt.edu

    Michael L Boninger, MD

    Recruiting

Other trials in United States

About this study

Official title: A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Significant Upper Limb Impairment

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.

Read the 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."

Being tested
Implantation of CRS Arrays
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
Medical subject headings
Quadriplegia, Spinal Cord Injuries, Brain Stem Infarctions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantation of CRS ArraysDevice

    Also called neuroprosthetic, brain-machine interface, brain-computer interface, microelectrode

    Two Blackrock Microsystems CRS Arrays will be implanted in the motor cortex and sensory cortex of study participants.

Study groups in NCT01894802
Study groupRoleWhat they receive
Brain-Machine Interface UsersExperimentalAll 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.
Receives: Device: Implantation of CRS Arrays

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One year following array implantation

Secondary outcomes (1)

  1. 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.

    Measured: One year following array implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2013 (estimated)
  2. Study start1 Dec 2013
  3. Primary completionAug 2027 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01894802
Sponsor's protocol ID
STUDY19100269
Acronym
CRS-BMI
Status last verified
May 2026
First submitted
3 Jul 2013
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The investigators will share de-identified data and study materials with collaborators.

Publications

  • Greenspon CM, Hobbs TG, Verbaarschot C, Alamri AH, Shelchkova ND, Lienkamper R, Ye J, Simpson TW, Weiss JM, Weir DM, Harrington DE, Van Driesche A, Satzer D, Valle G, Miller LE, Hatsopoulos NG, Gonzalez-Martinez J, Warnke PC, Downey JE, Boninger ML, Collinger JL, Gaunt RA. Intracortical microstimulation in humans: a decade of safety and efficacy. medRxiv [Preprint]. 2025 Aug 13:2025.08.11.25332271. doi: 10.1101/2025.08.11.25332271.

    PubMed 40832410

  • Hobbs TG, Greenspon CM, Verbaarschot C, Valle G, Hughes CL, Boninger ML, Bensmaia SJ, Gaunt RA. Biomimetic stimulation patterns drive natural artificial touch percepts using intracortical microstimulation in humans. J Neural Eng. 2025 May 14;22(3). doi: 10.1088/1741-2552/adc2d4.

    PubMed 40106898

  • Kunigk NG, Schone HR, Gontier C, Hockeimer W, Tortolani AF, Hatsopoulos NG, Downey JE, Chase SM, Boninger ML, Dekleva BD, Collinger JL. Motor somatotopy impacts imagery strategy success in human intracortical brain-computer interfaces. J Neural Eng. 2025 Mar 5;22(2):026004. doi: 10.1088/1741-2552/adb995.

    PubMed 39993333

  • Tortolani AF, Kunigk NG, Sobinov AR, Boninger ML, Bensmaia SJ, Collinger JL, Hatsopoulos NG, Downey JE. How different immersive environments affect intracortical brain computer interfaces. J Neural Eng. 2025 Feb 10;22(1):016032. doi: 10.1088/1741-2552/adb078.

    PubMed 39883960

  • Dekleva BM, Collinger JL. Using transient, effector-specific neural responses to gate decoding for brain-computer interfaces. J Neural Eng. 2025 Feb 11;22(1):016036. doi: 10.1088/1741-2552/adaa1f.

    PubMed 39808922

  • Downey JE, Schone HR, Foldes ST, Greenspon C, Liu F, Verbaarschot C, Biro D, Satzer D, Moon CH, Coffman BA, Youssofzadeh V, Fields D, Hobbs TG, Okorokova E, Tyler-Kabara EC, Warnke PC, Gonzalez-Martinez J, Hatsopoulos NG, Bensmaia SJ, Boninger ML, Gaunt RA, Collinger JL. A Roadmap for Implanting Electrode Arrays to Evoke Tactile Sensations Through Intracortical Stimulation. Hum Brain Mapp. 2024 Dec 15;45(18):e70118. doi: 10.1002/hbm.70118.

    PubMed 39720868

  • 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.

    PubMed 34847547

  • 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.

    PubMed 32494819

  • 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.

    PubMed 30429772

  • 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.

    PubMed 29553484

  • 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.

    PubMed 29209023

  • 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.

    PubMed 26987662

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of CRS Arrays in people with Tetraplegia and Spinal Cord Injury, run by Michael Boninger at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olivia L Campbell (412-648-4192, OLA22@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome is the safety of the participant. (time frame: One year following array implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01894802, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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