Investigation on the Cortical Communication System (CortiCom)

Investigation on the Cortical Communication (CortiCom) System

The goal of this clinical trial is to demonstrate communication through a brain implant in people in locked-in state, i.e. people with severe paralysis and communication problems.

The main questions it aims to answer are efficient and stable control of Brain-Computer interface (BCI) functions for communication with attempted hand movements and operation of a keyword-based speech BCI.

Participants will be implanted with four electrode grids, with in total 128 electrodes, on the surface of the brain and a connector on the skull. Participation includes visits of researchers for recording and training at home, 2-3 times per week for one year. Extension of participation after one year is possible.

If successful, the participant will be able to use the BCI at home independently, without the presence of a researcher.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Diseases; Traumatic Brain Injury; Locked-in Syndrome; Brainstem Stroke
• Intervention / Treatment: Device: ECoG (electrocorticography) sensing

Detailed Description

Locked-In Syndrome (LIS) is a neurological condition in which communication is impossible, or profoundly impaired, due to loss of speech and other motor functions, while cognition is intact. The most distressing aspect of LIS is the inability to initiate and sustain communication. Existing assistive technologies (ATs) fall short of a remedy. An effective brain-computer interface (BCI) for communication would dramatically improve quality of life for people with LIS. Electrocorticography (ECoG) with non-penetrating subdural electrodes is a promising implantable approach for BCI. In this study, the "CortiCom system" (which stands for Cortical Communication) wil be used. This system combines an implantable assembly, consisting of four small high-density (HD) ECoG grids on the hand and speech areas of the motor cortex, totalling 128-channels, and a transcutaneous pedestal connector, with an external data acquisition system. With the CortiCom system the overall hypothesis will be tested that broader and more densely spaced ECoG electrodes can better tap into the spatial detail of the organization of the sensorimotor cortex in order to expand BCI function and restore meaningful communication in LIS. Specifically, the CortiCom system will substantially increase the number and density of electrodes recording from the brain to determine whether more sophisticated control and communication can be achieved with more comprehensive and detailed spatial sampling of representations for movements of the hand/arm and of speech articulators. Clinically meaningful outcomes for people with LIS include rapid reestablishment, and stable maintenance of communication, at minimum consisting of a caregiver call-button and menu selections.

Objective:

Primary Objective 1: Demonstrate efficient and stable control of essential BCI functions (initiate BCI, call caregiver, and menu selections). Primary Objective 2: Demonstrate efficient and stable operation of a keyword-based speech BCI.

Intervention:

Participants will be implanted with an assembly consisting of HD-ECoG electrode grids over the sensorimotor cortex and a transcutaneous pedestal connector. The assembly will be connected with an external data acquisition system during recordings. During recordings, feedback about the neural signals is given via a visual display and participants are trained to employ the neural signals for fast brain-based communication. Upon adequate performance, participants can independently (i.e., without researcher involvement) train with and use the system at home for validation of performance and usability. After implantation, participation has a duration of 1 year, with a possibility of extension.

• Study Type: Interventional
• Enrollment (Estimated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariska J Vansteensel, PhD; Phone Number: +31887555121; Email: neuroprothese@umcutrecht.nl
• Study Contact Backup: Name: Erik J Aarnoutse, PhD; Phone Number: +31887555123; Email: e.j.aarnoutse@umcutrecht.nl

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584CX
    • Recruiting
    • University Medical Center
    • Contact: Mariska J Vansteensel, PhD; Phone Number: +31887555121; Email: neuroprothese@umcutrecht.nl
    • Contact: Erik J Aarnoutse, PhD; Phone Number: +31887555123; Email: e.j.aarnoutse@umcutrecht.nl
    • Principal Investigator: Nick F Ramsey, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-70 years
• Clinical diagnosis of locked-in state caused by traumatic brain injury, brainstem stroke, neurodegenerative disease, neuromuscular disease or another cause
• Complete or incomplete tetraplegia (quadriplegia) or tetraparesis (quadriparesis)
• Motor-related speech impairment (dysarthria or anarthria)
• Either receiving tracheostomy invasive ventilation, or having a stable and adequate respiratory situation without respiratory support, allowing for safe intubation, mechanical ventilation and detubation during surgery according to the involved clinicians, and, if relevant (e.g., in case of a progressive condition), in combination with a confirmed desire to receive tracheostomy invasive ventilation when that becomes necessary
• Meeting surgical safety criteria, including surgical clearance by the study physicians
• Meeting (neuro)psychological evaluation criteria
• Ability to communicate reliably, such as through eye movement
• Willingness and ability to provide informed consent
• Lives within reasonable distance from University Medical Center Utrecht
• Participant consents to the study and still wishes to participate at the time of the study
• Vision and hearing largely intact

Exclusion Criteria:

• Performance on formal neuropsychological testing that indicates a significant current or recent psychiatric disorder, cognitive or behavioral impairment, that would interfere with obtaining informed consent or fully participating in study activities
• Medical conditions contraindicating surgery of a chronically implanted device or that could interfere with study participation (for example active infections, unexplained fever, existing scalp lesions or skin breakdown, osteomyelitis, hepatitis, any autoimmune disease/disorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, cranioplasty, significant cardiovascular, metabolic, or renal impairments, 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 or a medical contraindication to stop anti-coagulant medications during surgery)
• Presence of pre-surgical findings in anatomical, functional, and/or vascular neuroimaging that makes achieving implant locations too challenging or incompatible with desired risk levels
• Inability to undergo MRI for pre-implantation evaluation, for example due to the presence of 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
• Anticipated need for MRI after implantation of the CortiCom assembly

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECoG (electrocorticography) sensing; Use implantable ECoG-based Brain Computer interface to control assistive technology	Device: ECoG (electrocorticography) sensing; Implant electrodes and pedestal connector and use, through amplifier and decoding, for control of BCI; Other Names: CortiCom-Utrecht assembly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the BCI system - Accuracy	Accuracy: >80% sensitivity (true positive rate) for 1-command control, and 90% sensitivity and 80% classification accuracy (distinguishing between the six classes) for 6-command control	1 year
Usability of the BCI system - speed	Speed characters or keywords per minute	1 year
Usability of the BCI system - subjective workload VAS	Subjective Workload: Visual Analogue Scale Continuous scale: Little to no effort (0) - Much effort (5). Lower numbers are better.	1 year
Usability of the BCI system - subjective workload NASA-TLX	Subjective Workload: National Aeronautics and Space Administration-Task Load Index Scale: 21 point Likert-type scale. Lower numbers are better.	1 year
Usability of the BCI system - user satisfaction PIADS	User Satisfaction: Psychosocial impact of assistive devices scale. Likert-type scale -3, -2, -1, 0, 1, 2, 3. 3 is best result.	1 year
Usability of the BCI system - user satisfaction QUEST	User Satisfaction: Quebec User Evaluation of Satisfaction with assistive Technology. Likert-type scale: Extremely dissatisfied - Dissatisfied - Slightly satisfied - Satisfied - Extremely satisfied. Extremely Satisfied is the best result.	1 year
Usability of the BCI system - validation	Validation: Questionnaire to evaluate user satisfaction and ease of use of the home use software. Likert-type scale: fully disagree - disagree - neither agree or disagree - agree - fully agree - not applicable. Fully agree is the best result.	1 year
Degrees of Freedom of BCI Control.	the number of different commands that are successfully decoded, or the size of the decoded vocabulary	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stability of BCI performance (electrode-tissue interaction)	Longitudinal data of the 24-hour cycle after implantation of the impedance (in Ω). The data are fitted to determine trends and variance, over weeks, to determine improvement or deterioration of electrode-tissue interaction.	2 years
Stability of BCI performance (signal)	Longitudinal data of the 24-hour cycle after implantation of the raw power (after wavelet transform, in arbitrary units). The data are fitted to determine trends and variance, both within 24 hrs to detect a possible circadian pattern and over weeks, to determine improvement or deterioration of signal amplitude.	2 years
Stability of BCI performance (modulation)	Longitudinal data of the 24-hour cycle after implantation of the task-related modulation in power (correlation in r2). The data are fitted to determine trends and variance, over weeks, to determine improvement or deterioration of modulation.	2 years
Stability of BCI performance (performance)	Longitudinal data of the 24-hour cycle after implantation of the BCI performance (task accuracy). The data are fitted to determine trends and variance, both within 24 hrs to detect a possible circadian pattern and over weeks, to see improvement or deterioration of accuracy.	2 years
Independent use of BCI	Longitudinal data of independent use per day. The best result is 24h use. The data are fitted to determine trends and variance, both within 24 hrs to detect a possible circadian pattern and over weeks, to see increase or decrease of the hours of independent use.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess device specifications for future application of HD ECoG-BCIs	qualitative description on device specifications and experimental parameters, such as the specific decoder settings, for future, larger scale, application of HD ECoG-BCIs.	2 years

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Nick F Ramsey, PhD, UMC Utrecht

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Estimated): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Amyotrophic lateral sclerosis; Neurodegenerative disease; Locked-in
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Ischemia; Infarction; Stroke; Brain Infarction; Paralysis; Quadriplegia; Brain Injuries; Brain Injuries, Traumatic; Neuromuscular Diseases; Brain Stem Infarctions; Locked-In Syndrome
• Other Study ID Numbers: UMCU 23-171; NL81205.041.23 (Other Identifier: NedMec)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: selected datasets will be available through a public repository after publication of results
• IPD Sharing Time Frame: after first published results, no end date
• IPD Sharing Access Criteria: Publicly available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No