TetraplegiaNCT01364480
Microelectrode Brain-Machine Interface for Individuals With Tetraplegia
A study testing Implantation of NeuroPort Arrays in the motor cortex in people with Tetraplegia and Spinal Cord Injury, run by Michael Boninger at 1 site in United States.
Trial summary
The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain activity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tetraplegia, Spinal Cord Injury
- What is being tested?
- Implantation of NeuroPort Arrays in the motor cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2011to 26 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Limited or no ability to use both hands due to cervical spinal cord injury or brainstem or spinal stroke
- At least 1 year post-injury
- Live within 1 hour of the University of Pittsburgh and be willing to travel to the University of Pittsburgh once per week for BMI training
- Additional inclusion criteria must also be reviewed
Who cannot join
- Certain implanted devices
- Presence of other serious disease or disorder that could affect ability to participate in this study
- Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise
- Additional exclusion criteria must also be reviewed
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain activity.
Read the detailed description
Individuals with tetraplegia (paralysis caused by illness or injury that results in partial or total loss of 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 signals are generated even though they are not sent to the arms, hands and legs. By implanting electrodes in 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.
- Conditions
- Tetraplegia, Spinal Cord Injury
- Being tested
- Implantation of NeuroPort Arrays in the motor cortex
- Keywords
- Tetraplegia, Spinal cord injury, Brainstem or spinal stroke, Neuroprosthetic, Brain-machine interface, Brain-computer interface, Neural activity
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of NeuroPort Arrays in the motor cortexDevice
Also called neuroprosthetic, brain-machine interface, brain-computer interface
Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.
| Study group | Role | What they receive |
|---|---|---|
| Brain-Machine Interface Users | Experimental | All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group. Receives: Device: Implantation of NeuroPort Arrays in the motor cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Implant
Number of participants who were implanted for at least one year without having to explant the device for safety reasons.
Measured: One year following array implantation
Secondary outcomes (2)
7 Degree-of-freedom Movement by Neural Control
A modified Action Research Arm Test (ARAT) assessment for upper extremity performance was conducted to evaluate neural control of movement of a robotic prosthetic arm with 7 independent degrees of freedom controlled simultaneously. The degrees of freedom included: 3D translation of arm, 3D orientation of wrist, and 1D open/closing of hand. The participant used a brain-controlled robotic hand to do 9 tasks (out of 19). Each test item was timed and scored as 0 (no movement), 1 (task partly done), 2 (task done, but not correctly), or 3 (task done correctly). Movements that required more than 5 s to complete were scored as 2. The participant attempted each assessment three times and the best score was included. The total possible score ranged from 0 to 27 (i.e., max possible score of 3 each for 9 total tasks). A higher score indicates a better outcome.
Measured: One year following array implantation
10 Degree-of-freedom Movement by Neural Control
A modified ARAT was conducted to assess neural control of movement of a robotic prosthetic arm with 10 independent degrees of freedom, controlled simultaneously. Degrees of freedom included: 3D translation of arm, 3D orientation of wrist, and 4 degrees dictating hand shape, including pinch (flexion of thumb, index and middle fingers), scoop (flexion of ring and pinky fingers), finger abduction (of index, ring and little fingers), and thumb opposition. The participant used a brain-controlled robotic hand to do 9 tasks (out of 19). Test items were timed and scored as 0 (no movement), 1 (task partly done), 2 (task done, but not correctly), or 3 (task done correctly). Movements that required more than 5 s to complete were scored as 2. The participant attempted each assessment three times and the best score was included. The total possible score ranged from 0 to 27 (i.e., max possible score of 3 each for 9 total tasks). A higher score indicates a better outcome.
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.
- First posted2 Jun 2011 (estimated)
- Study start1 May 2011
- Primary completion26 Nov 2022
- Study completion26 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Boninger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Boninger, University of Pittsburgh
- Investigators
- Michael L Boninger, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364480
- Sponsor's protocol ID
- STUDY19030235
- Status last verified
- Nov 2023
- First submitted
- 25 May 2011
- Last updated
- 9 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We may share de-identified data with collaborators.
Publications
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 34847547Downey 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 32494819Downey 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 29553484Downey 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 29209023Downey 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 26987662Wodlinger B, Downey JE, Tyler-Kabara EC, Schwartz AB, Boninger ML, Collinger JL. Ten-dimensional anthropomorphic arm control in a human brain-machine interface: difficulties, solutions, and limitations. J Neural Eng. 2015 Feb;12(1):016011. doi: 10.1088/1741-2560/12/1/016011. Epub 2014 Dec 16.
PubMed 25514320Collinger JL, Wodlinger B, Downey JE, Wang W, Tyler-Kabara EC, Weber DJ, McMorland AJ, Velliste M, Boninger ML, Schwartz AB. High-performance neuroprosthetic control by an individual with tetraplegia. Lancet. 2013 Feb 16;381(9866):557-64. doi: 10.1016/S0140-6736(12)61816-9. Epub 2012 Dec 17.
PubMed 23253623
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microelectrode Brain-Machine Interface for Individuals With Tetraplegia
- ClinicalTrials.gov ID
- NCT01364480
- Acronym / sponsor ID
- STUDY19030235
- Conditions
- Tetraplegia, Spinal Cord Injury
- Keywords
- Tetraplegia, Spinal cord injury, Brainstem or spinal stroke, Neuroprosthetic, Brain-machine interface, Brain-computer interface, Neural activity
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Michael BoningerUniversity, hospital or other
- Study start
- 1 May 2011 (actual)
- Primary completion
- 26 Nov 2022 (actual)
- Study completion
- 26 Nov 2022 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Posted 9 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain activity.
Detailed description
Individuals with tetraplegia (paralysis caused by illness or injury that results in partial or total loss of 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 signals are generated even though they are not sent to the arms, hands and legs. By implanting electrodes in 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain-Machine Interface Users | Experimental | Device: Implantation of NeuroPort Arrays in the motor cortexAll participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Limited or no ability to use both hands due to cervical spinal cord injury or brainstem or spinal stroke
- At least 1 year post-injury
- Live within 1 hour of the University of Pittsburgh and be willing to travel to the University of Pittsburgh once per week for BMI training
- Additional inclusion criteria must also be reviewed
Key exclusion criteria (4 listed)
- Certain implanted devices
- Presence of other serious disease or disorder that could affect ability to participate in this study
- Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise
- Additional exclusion criteria must also be reviewed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of NeuroPort Arrays in the motor cortexAlso: neuroprosthetic, brain-machine interface, brain-computer interfaceTwo Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants. | Device | Brain-Machine Interface Users |
Primary outcome
Number of Participants With Successful Implant
Time frame: One year following array implantation
Number of participants who were implanted for at least one year without having to explant the device for safety reasons.
2 secondary outcomes
7 Degree-of-freedom Movement by Neural Control
Time frame: One year following array implantation
10 Degree-of-freedom Movement by Neural Control
Time frame: One year following array implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34847547Sponheim 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.
- Derived from this study: PubMed 32494819Downey 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.
- Derived from this study: PubMed 29553484Downey 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.
- Derived from this study: PubMed 29209023Downey 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.
- Derived from this study: PubMed 26987662Downey 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.
- Derived from this study: PubMed 25514320Wodlinger B, Downey JE, Tyler-Kabara EC, Schwartz AB, Boninger ML, Collinger JL. Ten-dimensional anthropomorphic arm control in a human brain-machine interface: difficulties, solutions, and limitations. J Neural Eng. 2015 Feb;12(1):016011. doi: 10.1088/1741-2560/12/1/016011. Epub 2014 Dec 16.
- Derived from this study: PubMed 23253623Collinger JL, Wodlinger B, Downey JE, Wang W, Tyler-Kabara EC, Weber DJ, McMorland AJ, Velliste M, Boninger ML, Schwartz AB. High-performance neuroprosthetic control by an individual with tetraplegia. Lancet. 2013 Feb 16;381(9866):557-64. doi: 10.1016/S0140-6736(12)61816-9. Epub 2012 Dec 17.
- Individual participant dataSharing planned: Yes. We may share de-identified data with collaborators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Boninger, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of NeuroPort Arrays in the motor cortex in people with Tetraplegia and Spinal Cord Injury, run by Michael Boninger at 1 site 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Implant (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 NCT01364480, which also lists 7 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 9 Jan 2024.