Investigation on the Cortical Communication (CortiCom) System

NCT03567213 | Recruiting DMC FDA Device

• 2 other identifiers: IRB00167247UH3NS114439
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.

Conditions

Tetraplegia; Locked-in Syndrome; Brainstem Stroke; Amyotrophic Lateral Sclerosis

Keywords

Tetraplegia; ALS; Locked-in Syndrome; Brainstem stroke; Brain Computer Interface; Rehabilitation; Stroke; Hopkins

Outcome Measures

Primary Outcomes (1)

• 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.

  26 weeks

Secondary Outcomes (2)

• Success rate in controlling the brain computer interface, i.e. ratio of successful trials to total trials.

  26 weeks

• Speed of brain-computer interface control, i.e. time to complete successful trials (in seconds).

  26 weeks

Study Arms (1)

Surgical implantation of the CortiCom system

EXPERIMENTAL

Device: Surgical implantation of CortiCom system

Interventions

Surgical implantation of CortiCom system DEVICE

Implantation of Cortical communication system, consisting of one or two Electrocorticography (ECoG) grids connected to a transcutaneous patient pedestal.

Surgical implantation of the CortiCom system

Eligibility Criteria

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

You may qualify if:

• 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.
• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (8)

• Candrea 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.

  PMID: 41256173 DERIVED

• Angrick 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.

  PMID: 40972658 DERIVED

• Candrea 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.

  PMID: 39433597 DERIVED

• Angrick 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.

  PMID: 39371161 DERIVED

• Wyse-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.

  PMID: 38925110 DERIVED

• Angrick 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.

  PMID: 38671062 DERIVED

• Crone 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.

  PMID: 37841873 DERIVED

• Angrick 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.

  PMID: 37425721 DERIVED

Related Links

• Additional study information

MeSH Terms

Conditions

Quadriplegia; Locked-In Syndrome; Brain Stem Infarctions; Amyotrophic Lateral Sclerosis; Stroke

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Spinal Cord Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nathan E Crone, MD

  Professor of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan E Crone, MD

CONTACT

410-955-6772; ncrone@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 25, 2018
• Study Start: December 14, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: IPD and associated analytic code will be made available upon publication of research results and will remain available for the duration of the funded project.

Locations

US (1)