Cortical Recording and Stimulating Array Brain-Machine Interface

NCT01894802 | Recruiting DMC FDA Device

• 1 other identifier: STUDY19100269
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  One year following array implantation

Secondary Outcomes (1)

• The secondary outcome is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices.

  One year following array implantation

Study Arms (1)

Brain-Machine Interface Users

EXPERIMENTAL

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

Interventions

Implantation of CRS Arrays DEVICE

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

Also known as: neuroprosthetic, brain-machine interface, brain-computer interface, microelectrode, array

Brain-Machine Interface Users

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Michael Boninger: lead
• University of Chicago: collaborator
• Carnegie Mellon University: collaborator
• Northwestern University: collaborator
• Sinai Health System: collaborator

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 40832410 DERIVED

• 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.

  PMID: 40106898 DERIVED

• 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.

  PMID: 39883960 DERIVED

• 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.

  PMID: 39808922 DERIVED

• 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.

  PMID: 34847547 DERIVED

• 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.

  PMID: 32494819 DERIVED

• 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.

  PMID: 30429772 DERIVED

• 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.

  PMID: 29553484 DERIVED

• 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.

  PMID: 29209023 DERIVED

• 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.

  PMID: 26987662 DERIVED

Related Links

• University of Pittsburgh Medical Center / Brain-Computer Interface Media Page
• Rehabilitation and Neural Engineering Laboratory

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries; Brain Stem Infarctions

Interventions

Brain-Computer Interfaces; Microelectrodes

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Electrodes

Study Officials

• Michael L Boninger, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia L Campbell

CONTACT

412-648-4192; OLA22@pitt.edu

Debbie Harrington

CONTACT

412-383-1355; debbie.harrington@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator / Sponsor-Investigator

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 10, 2013
• Study Start: December 1, 2013
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (2)