TetraplegiaCortiComNCT03567213
Investigation on the Cortical Communication (CortiCom) System
A study testing Surgical implantation of CortiCom system in people with Tetraplegia and Locked-in Syndrome, run by Johns Hopkins University at 1 site in United States.
Trial summary
The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Tetraplegia, Locked-in Syndrome, Brainstem Stroke
- What is being tested?
- Surgical implantation of CortiCom system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 31 Dec 2030
- 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
- Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS)
- Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment
- Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), or severe ataxia. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in LIS.
- 22-70 years
- Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants
- Ability to communicate reliably, such as through eye movement
Show all 11Show fewer
- Willingness and ability to provide informed consent
- Screened by rehabilitation psychologist with a result showing that the participant has a stable psychosocial support system with caregiver capable of monitoring participant throughout the study
- Ability and willingness to travel up to 100 miles to study location up to three days per week for the duration of the study
- Ability to understand and comply with study session instructions
- Participant consents to the study and still wishes to participate at the time of the study
Who cannot join
- Performance on formal neuropsychological testing that indicates significant psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.
- Suicide attempt or persistent suicidal ideation within the past 12 months.
- Implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants.
- History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months
- Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease/disorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation)
- Other chronic, unstable medical conditions that could interfere with subject participation.
Show all 21Show fewer
- Presence of pre-surgical findings in anatomical, functional, and/or vascular neuroimaging that makes achieving implant locations within desired risk levels too challenging (to be decided by neurological and neurosurgical team)
- Prior cranioplasty
- Inability to undergo MRI or anticipated need for an MRI during the study period
- Participants with active infections or unexplained fever
- Participants with other morbid conditions making the implantation of the recording elements unsafe; not limited to: significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe
- Pregnancy (confirmation through blood test)
- Nursing an infant, planning to become pregnant, or not using adequate birth control
- Corrected vision poorer than 20/100
- HIV or AIDS infection
- Existing scalp lesions or skin breakdown
- Chronic oral or intravenous use of steroids or immunosuppressive therapy
- Active cancer within the past year or requires chemotherapy
- Uncontrolled autonomic dysreflexia within the past 3 months
- Hydrocephalus with or without an implanted ventricular shunt
- Participants in whom it is medically contraindicated to stop anti-coagulant medications during surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Medicine
Baltimore, Maryland, 21205
Nathan E Crone, MD, 410-955-6772, ncrone@jhmi.edu
Nathan E Crone, MD
About this study
The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.
Read the detailed description
The successful adoption of brain-computer interfaces (BCIs) as assistive technologies (ATs) for disabled populations depends on the ability to elicit rapid, intuitive, and reliable control signals. To date, it is not known which sources of neural information provide the most natural and efficient means of control. This study will directly assess the efficacy of two sources of neural control signals, speech and motor cortex, for BCI control of software and devices using investigators' Cortical Communication (CortiCom) system.
The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.
Investigators' study will be the first to investigate the efficiency and intuitiveness of two contrasting neural control strategies for BCI: Motor imagery and speech. As the first study to chronically and simultaneously record from human speech and motor regions, this study seeks to achieve the following:
- demonstrate the ability to decode intended upper extremity movements using information decoded from primary motor cortex arm/hand area;
- demonstrate the ability to decode intended speech from articulatory speech cortex; and
- determine the most effective and intuitive user strategies (e.g. imagined speech or imagined movement) and optimal neural sources for brain-computer interactions,
The patient populations targeted in this study are amyotrophic lateral sclerosis (ALS), brainstem stroke, locked-in syndrome (LIS), and tetraplegia. Individuals within these populations may have normal cortical function and cognition while suffering from motor or combined speech and motor deficits.
Based on research by colleagues, as well as investigators' own experience working with participants affected by epilepsy implanted with high density electrocorticographic grids, investigators hypothesize that long-term recording of neural activity from the targeted cortical areas may provide a new communication channel for these clinical populations. The utilization of high-channel-count (up to 128 channel) ECoG grids, in combination with simultaneous coverage of speech and motor cortex, will enable investigations into the performance of speech-mediated and motor-mediated control efficacy as applied to a variety of end effectors, such as computers, tablets, headsets for virtual or augmented reality, smart lights, televisions, and assistive technologies. Additionally, eye-tracking may be utilized in combination with neural commands to improve target selection performance and ease.
Through this study, investigators will assess the performance of speech- and motor-mediated control using chronic, high-channel count ECoG grid neural implants in pursuit of a high-performing, clinically beneficial BCI assistive technology.
- Being tested
- Surgical implantation of CortiCom system
- Keywords
- Tetraplegia, ALS, Locked-in Syndrome, Brainstem stroke, Brain Computer Interface, Rehabilitation, Stroke, Hopkins
- Medical subject headings
- Quadriplegia, Locked-In Syndrome, Brain Stem Infarctions, Amyotrophic Lateral Sclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical implantation of CortiCom systemDevice
Implantation of Cortical communication system, consisting of one or two Electrocorticography (ECoG) grids connected to a transcutaneous patient pedestal.
| Study group | Role | What they receive |
|---|---|---|
| Surgical implantation of the CortiCom system | Experimental | Not described Receives: Device: Surgical implantation of CortiCom system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to device explantation
This study outcome will be considered successful if the device is not explanted during the 26-week period of the study. Explantation of the device prior to the completion of the 26-week period implies that the device is putting the subject at risk (e.g. through a serious infection at the implantation site) and therefore must be removed.
Measured: 26 weeks
Secondary outcomes (2)
Success rate in controlling the brain computer interface, i.e. ratio of successful trials to total trials.
One or more participants demonstrates successful use of the CortiCom system in which motor and/or speech neural signals can be decoded to provide control signals for software and devices. Efficacy is assessed in terms of accuracy, i.e. how often the participant is able to select a desired target.
Measured: 26 weeks
Speed of brain-computer interface control, i.e. time to complete successful trials (in seconds).
One or more participants demonstrates successful use of the CortiCom system in which motor and/or speech neural signals can be decoded to provide control signals for software and devices. Efficacy is therefore also assessed in terms of how long it takes to select the target.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start14 Dec 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan E Crone, MD, Principal investigator, Professor of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567213
- Sponsor's protocol ID
- IRB00167247
- Other IDs
- UH3NS114439
- Acronym
- CortiCom
- Status last verified
- Aug 2026
- First submitted
- 21 May 2018
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD from published results will be made available upon reasonable request to corresponding authors and/or will be uploaded to a data archive for the BRAIN Initiative in compliance with its data sharing consortium.
Publications
Ouyang Z, Walmsley K, Luo S, Tippett D, Wyse-Sookoo K, Fifer M, Vansteensel MJ, Angrick M, Ramsey N, Crone NE. Stable speech BCI performance during slow progression of ALS: A longitudinal ECoG study. Res Sq [Preprint]. 2026 Mar 25:rs.3.rs-9156039. doi: 10.21203/rs.3.rs-9156039/v1.
PubMed 41928799Candrea DN, Angrick M, Luo S, Ganji R, Coogan C, Milsap GW, Rosenblatt KR, Uchil A, Clawson L, Maragakis NJ, Vansteensel MJ, Tenore FV, Ramsey NF, Fifer MS, Crone NE. Longitudinal study of gesture decoding in a clinical trial participant with ALS. medRxiv [Preprint]. 2025 Oct 3:2025.09.26.25335804. doi: 10.1101/2025.09.26.25335804.
PubMed 41256173Angrick M, Luo S, Rabbani Q, Joshi S, Candrea DN, Milsap GW, Gordon CR, Rosenblatt K, Clawson L, Maragakis N, Tenore FV, Fifer MS, Ramsey NF, Crone NE. Real-time detection of spoken speech from unlabeled ECoG signals: a pilot study with an ALS participant. J Neural Eng. 2025 Oct 6;22(5):056023. doi: 10.1088/1741-2552/ae0965.
PubMed 40972658Candrea DN, Shah S, Luo S, Angrick M, Rabbani Q, Coogan C, Milsap GW, Nathan KC, Wester BA, Anderson WS, Rosenblatt KR, Uchil A, Clawson L, Maragakis NJ, Vansteensel MJ, Tenore FV, Ramsey NF, Fifer MS, Crone NE. A click-based electrocorticographic brain-computer interface enables long-term high-performance switch scan spelling. Commun Med (Lond). 2024 Oct 22;4(1):207. doi: 10.1038/s43856-024-00635-3.
PubMed 39433597Angrick M, Luo S, Rabbani Q, Joshi S, Candrea DN, Milsap GW, Gordon CR, Rosenblatt K, Clawson L, Maragakis N, Tenore FV, Fifer MS, Ramsey NF, Crone NE. Real-time detection of spoken speech from unlabeled ECoG signals: A pilot study with an ALS participant. medRxiv [Preprint]. 2024 Sep 22:2024.09.18.24313755. doi: 10.1101/2024.09.18.24313755.
PubMed 39371161Wyse-Sookoo K, Luo S, Candrea D, Schippers A, Tippett DC, Wester B, Fifer M, Vansteensel MJ, Ramsey NF, Crone NE. Stability of ECoG high gamma signals during speech and implications for a speech BCI system in an individual with ALS: a year-long longitudinal study. J Neural Eng. 2024 Jul 12;21(4):10.1088/1741-2552/ad5c02. doi: 10.1088/1741-2552/ad5c02.
PubMed 38925110Angrick M, Luo S, Rabbani Q, Candrea DN, Shah S, Milsap GW, Anderson WS, Gordon CR, Rosenblatt KR, Clawson L, Tippett DC, Maragakis N, Tenore FV, Fifer MS, Hermansky H, Ramsey NF, Crone NE. Online speech synthesis using a chronically implanted brain-computer interface in an individual with ALS. Sci Rep. 2024 Apr 26;14(1):9617. doi: 10.1038/s41598-024-60277-2.
PubMed 38671062Crone N, Candrea D, Shah S, Luo S, Angrick M, Rabbani Q, Coogan C, Milsap G, Nathan K, Wester B, Anderson W, Rosenblatt K, Clawson L, Maragakis N, Vansteensel M, Tenore F, Ramsey N, Fifer M, Uchil A. A click-based electrocorticographic brain-computer interface enables long-term high-performance switch-scan spelling. Res Sq [Preprint]. 2023 Sep 25:rs.3.rs-3158792. doi: 10.21203/rs.3.rs-3158792/v1.
PubMed 37841873Angrick M, Luo S, Rabbani Q, Candrea DN, Shah S, Milsap GW, Anderson WS, Gordon CR, Rosenblatt KR, Clawson L, Maragakis N, Tenore FV, Fifer MS, Hermansky H, Ramsey NF, Crone NE. Online speech synthesis using a chronically implanted brain-computer interface in an individual with ALS. medRxiv [Preprint]. 2023 Jul 1:2023.06.30.23291352. doi: 10.1101/2023.06.30.23291352.
PubMed 37425721
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Cortical Communication (CortiCom) System
- ClinicalTrials.gov ID
- NCT03567213
- Acronym / sponsor ID
- CortiCom / IRB00167247
- Keywords
- Tetraplegia, ALS, Locked-in Syndrome, Brainstem stroke, Brain Computer Interface, Rehabilitation, Stroke, Hopkins
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.
Detailed description
The successful adoption of brain-computer interfaces (BCIs) as assistive technologies (ATs) for disabled populations depends on the ability to elicit rapid, intuitive, and reliable control signals. To date, it is not known which sources of neural information provide the most natural and efficient means of control. This study will directly assess the efficacy of two sources of neural control signals, speech and motor cortex, for BCI control of software and devices using investigators' Cortical Communication (CortiCom) system.
The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.
Investigators' study will be the first to investigate the efficiency and intuitiveness of two contrasting neural control strategies for BCI: Motor imagery and speech. As the first study to chronically and simultaneously record from human speech and motor regions, this study seeks to achieve the following:
- demonstrate the ability to decode intended upper extremity movements using information decoded from primary motor cortex arm/hand area;
- demonstrate the ability to decode intended speech from articulatory speech cortex; and
- determine the most effective and intuitive user strategies (e.g. imagined speech or imagined movement) and optimal neural sources for brain-computer interactions,
The patient populations targeted in this study are amyotrophic lateral sclerosis (ALS), brainstem stroke, locked-in syndrome (LIS), and tetraplegia. Individuals within these populations may have normal cortical function and cognition while suffering from motor or combined speech and motor deficits.
Based on research by colleagues, as well as investigators' own experience working with participants affected by epilepsy implanted with high density electrocorticographic grids, investigators hypothesize that long-term recording of neural activity from the targeted cortical areas may provide a new communication channel for these clinical populations. The utilization of high-channel-count (up to 128 channel) ECoG grids, in combination with simultaneous coverage of speech and motor cortex, will enable investigations into the performance of speech-mediated and motor-mediated control efficacy as applied to a variety of end effectors, such as computers, tablets, headsets for virtual or augmented reality, smart lights, televisions, and assistive technologies. Additionally, eye-tracking may be utilized in combination with neural commands to improve target selection performance and ease.
Through this study, investigators will assess the performance of speech- and motor-mediated control using chronic, high-channel count ECoG grid neural implants in pursuit of a high-performing, clinically beneficial BCI assistive technology.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical implantation of the CortiCom system | Experimental | Device: Surgical implantation of CortiCom system |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS)
- Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment
- Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), or severe ataxia. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in LIS.
- 22-70 years
- Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants
Key exclusion criteria (21 listed)
- Performance on formal neuropsychological testing that indicates significant psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.
- Suicide attempt or persistent suicidal ideation within the past 12 months.
- Implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants.
- History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months
- Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease/disorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation)
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 |
|---|---|---|
| Surgical implantation of CortiCom systemImplantation of Cortical communication system, consisting of one or two Electrocorticography (ECoG) grids connected to a transcutaneous patient pedestal. | Device | Surgical implantation of the CortiCom system |
Primary outcome
Time to device explantation
Time frame: 26 weeks
This study outcome will be considered successful if the device is not explanted during the 26-week period of the study. Explantation of the device prior to the completion of the 26-week period implies that the device is putting the subject at risk (e.g. through a serious infection at the implantation site) and therefore must be removed.
2 secondary outcomes
Success rate in controlling the brain computer interface, i.e. ratio of successful trials to total trials.
Time frame: 26 weeks
Speed of brain-computer interface control, i.e. time to complete successful trials (in seconds).
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 41928799Ouyang Z, Walmsley K, Luo S, Tippett D, Wyse-Sookoo K, Fifer M, Vansteensel MJ, Angrick M, Ramsey N, Crone NE. Stable speech BCI performance during slow progression of ALS: A longitudinal ECoG study. Res Sq [Preprint]. 2026 Mar 25:rs.3.rs-9156039. doi: 10.21203/rs.3.rs-9156039/v1.
- Derived from this study: PubMed 41256173Candrea DN, Angrick M, Luo S, Ganji R, Coogan C, Milsap GW, Rosenblatt KR, Uchil A, Clawson L, Maragakis NJ, Vansteensel MJ, Tenore FV, Ramsey NF, Fifer MS, Crone NE. Longitudinal study of gesture decoding in a clinical trial participant with ALS. medRxiv [Preprint]. 2025 Oct 3:2025.09.26.25335804. doi: 10.1101/2025.09.26.25335804.
- Derived from this study: PubMed 40972658Angrick M, Luo S, Rabbani Q, Joshi S, Candrea DN, Milsap GW, Gordon CR, Rosenblatt K, Clawson L, Maragakis N, Tenore FV, Fifer MS, Ramsey NF, Crone NE. Real-time detection of spoken speech from unlabeled ECoG signals: a pilot study with an ALS participant. J Neural Eng. 2025 Oct 6;22(5):056023. doi: 10.1088/1741-2552/ae0965.
- Derived from this study: PubMed 39433597Candrea DN, Shah S, Luo S, Angrick M, Rabbani Q, Coogan C, Milsap GW, Nathan KC, Wester BA, Anderson WS, Rosenblatt KR, Uchil A, Clawson L, Maragakis NJ, Vansteensel MJ, Tenore FV, Ramsey NF, Fifer MS, Crone NE. A click-based electrocorticographic brain-computer interface enables long-term high-performance switch scan spelling. Commun Med (Lond). 2024 Oct 22;4(1):207. doi: 10.1038/s43856-024-00635-3.
- Derived from this study: PubMed 39371161Angrick M, Luo S, Rabbani Q, Joshi S, Candrea DN, Milsap GW, Gordon CR, Rosenblatt K, Clawson L, Maragakis N, Tenore FV, Fifer MS, Ramsey NF, Crone NE. Real-time detection of spoken speech from unlabeled ECoG signals: A pilot study with an ALS participant. medRxiv [Preprint]. 2024 Sep 22:2024.09.18.24313755. doi: 10.1101/2024.09.18.24313755.
- Derived from this study: PubMed 38925110Wyse-Sookoo K, Luo S, Candrea D, Schippers A, Tippett DC, Wester B, Fifer M, Vansteensel MJ, Ramsey NF, Crone NE. Stability of ECoG high gamma signals during speech and implications for a speech BCI system in an individual with ALS: a year-long longitudinal study. J Neural Eng. 2024 Jul 12;21(4):10.1088/1741-2552/ad5c02. doi: 10.1088/1741-2552/ad5c02.
- Derived from this study: PubMed 38671062Angrick M, Luo S, Rabbani Q, Candrea DN, Shah S, Milsap GW, Anderson WS, Gordon CR, Rosenblatt KR, Clawson L, Tippett DC, Maragakis N, Tenore FV, Fifer MS, Hermansky H, Ramsey NF, Crone NE. Online speech synthesis using a chronically implanted brain-computer interface in an individual with ALS. Sci Rep. 2024 Apr 26;14(1):9617. doi: 10.1038/s41598-024-60277-2.
- Derived from this study: PubMed 37841873Crone N, Candrea D, Shah S, Luo S, Angrick M, Rabbani Q, Coogan C, Milsap G, Nathan K, Wester B, Anderson W, Rosenblatt K, Clawson L, Maragakis N, Vansteensel M, Tenore F, Ramsey N, Fifer M, Uchil A. A click-based electrocorticographic brain-computer interface enables long-term high-performance switch-scan spelling. Res Sq [Preprint]. 2023 Sep 25:rs.3.rs-3158792. doi: 10.21203/rs.3.rs-3158792/v1.
- Derived from this study: PubMed 37425721Angrick M, Luo S, Rabbani Q, Candrea DN, Shah S, Milsap GW, Anderson WS, Gordon CR, Rosenblatt KR, Clawson L, Maragakis N, Tenore FV, Fifer MS, Hermansky H, Ramsey NF, Crone NE. Online speech synthesis using a chronically implanted brain-computer interface in an individual with ALS. medRxiv [Preprint]. 2023 Jul 1:2023.06.30.23291352. doi: 10.1101/2023.06.30.23291352.
- Individual participant dataSharing planned: Yes. IPD from published results will be made available upon reasonable request to corresponding authors and/or will be uploaded to a data archive for the BRAIN Initiative in compliance with its data sharing consortium.
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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.
Nathan E Crone, MD principal investigator
Professor of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical implantation of CortiCom system in people with Tetraplegia and Locked-in Syndrome, run by Johns Hopkins University 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 11 inclusion and 21 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 21 Aug 2026. 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?
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 Nathan E Crone, MD (410-955-6772, ncrone@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to device explantation (time frame: 26 weeks). 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 NCT03567213, which also lists 9 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 21 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.