Implantation of brain-computer interface for communication in ALS, quadriplegia, and Locked In Syndrome

(CortiCom Trial)

Overseen By Nathan E Crone, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Steroids, Immunosuppressives, Chemotherapy, others

Disqualifiers: Diabetes, Epilepsy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 26 weeks

3 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the CortiCom System, a new system that could help people with severe movement and speech difficulties communicate and interact better. The treatment involves implanting small grids in the brain to pick up signals related to speech and movement. It is designed for individuals who have lived with conditions like ALS (a disease affecting nerve cells in the brain and spinal cord), brainstem stroke, or Locked-in Syndrome for at least a year. Candidates should have severe movement limitations and possibly speech difficulties but must still communicate reliably, such as through eye movement. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could transform communication methods for individuals with severe disabilities.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anti-coagulant medications, you may need to stop them during surgery.

What prior data suggests that the CortiCom system is safe for use in ALS patients?

Research has shown that the CortiCom system uses FDA-approved parts, indicating they meet safety standards for other uses. The system includes platinum electrode grids that connect the brain to a computer. These grids are placed on the brain's surface to help control devices using brain signals related to speech and movement.

In past studies with similar systems, patients generally handled the implants well, and serious side effects were not commonly reported. However, since placing the grids requires surgery, risks such as infection or discomfort exist. Potential participants should discuss these risks with medical professionals before joining any trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CortiCom System is unique because it involves a brain-computer interface specifically designed for ALS patients, offering a novel way to potentially enhance communication abilities. Unlike traditional treatments like medications that manage symptoms or slow disease progression, this system is surgically implanted to directly connect the brain to external devices, enabling thought-driven communication. Researchers are excited about this approach as it bypasses the need for muscle control, which is often impaired in ALS, and it could significantly improve the quality of life for patients by restoring their ability to communicate effectively.

What evidence suggests that the CortiCom system is effective for ALS?

Research has shown that the CortiCom system, which participants in this trial will receive, could assist people with paralysis, such as those with ALS (amyotrophic lateral sclerosis), in communicating. This system employs a brain-computer interface (BCI) to convert thoughts into actions on a computer. In earlier studies, similar technology enabled patients to type quickly and accurately by thought alone. The CortiCom system uses small sensors placed on the brain to detect signals related to speech and movement. These signals are processed to control devices, offering new ways for people to interact with their surroundings. Although still experimental, early results suggest it could enhance communication for those with ALS. ^{6 7 8 9 10}

Who Is on the Research Team?

Nathan E Crone, MD

Principal Investigator

Professor of Neurology

Are You a Good Fit for This Trial?

This trial is for adults aged 22-70 with conditions like Locked-In Syndrome, ALS, or tetraplegia due to brainstem stroke or injury. Participants must have had their condition for at least a year and be able to communicate through eye movement. People with active infections, epilepsy, substance abuse history, MRI incompatibility, certain medical conditions or surgeries that affect implant safety are excluded.

Inclusion Criteria

I have a condition that affects my speech and makes my arms or legs weak.

I have been diagnosed with ALS or motor neuron disease.

I have tetraplegia or quadriplegia due to a spinal cord injury.

Exclusion Criteria

I have been diagnosed with Epilepsy.

You have either tried to commit suicide or thought about it often within the past year.

You cannot have an MRI or will need an MRI during the study period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Surgical implantation of the CortiCom system, including platinum PMT subdural cortical electrode grids

1 week

1 visit (in-person)

Treatment

Participants use the CortiCom system to control software and devices using neural signals from speech and motor cortex

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CortiCom System

Trial Overview The CortiCom system involves surgically placing up to two electrode grids on the brain's surface over areas controlling speech and arm movements. This device aims to help people with severe paralysis communicate better by translating brain signals into speech or text.

How Is the Trial Designed?

Group I: Surgical implantation of the CortiCom system Experimental Treatment 1 Intervention

CortiCom System is already approved in United States for the following indications:

Approved in United States as CortiCom System for:

• Investigational use for speech and upper extremity movement encoding

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

The implanted electrocorticography (ECoG)-based brain-computer interface (BCI) demonstrated stable performance and control over a 36-month period in a patient with late-stage Amyotrophic Lateral Sclerosis (ALS), indicating its long-term efficacy for communication.

Despite a gradual decline in high-frequency power in the motor cortex, the user maintained effective control of the BCI, and the frequency of home use increased, showing successful adoption of the technology for daily communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability of a chronic implanted brain-computer interface in late-stage amyotrophic lateral sclerosis. Pels, EGM., Aarnoutse, EJ., Leinders, S., et al.[2020]

Brain-computer interfaces (BCIs) have been developed to help individuals with amyotrophic lateral sclerosis (ALS) regain communication abilities, which is crucial as ALS can lead to complete loss of voluntary control.

Research on BCIs for ALS patients emphasizes the importance of collaboration between researchers, clinicians, and patients to ensure that the technology is effectively integrated into daily life, addressing the unique challenges faced by those with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-computer interfaces for people with amyotrophic lateral sclerosis. Vaughan, TM.[2021]

A new hermetic package for brain-computer interfaces (BCIs) has been developed to protect electronic components from moisture while allowing infrared communication, which is crucial for implanted devices.

The package is made from alumina ceramic and is encased in a medical-grade silicone adhesive (MED2-4013), ensuring safety and durability for long-term use in severely impaired patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hermetic electronic packaging of an implantable brain-machine-interface with transcutaneous optical data communication. Schuettler, M., Kohler, F., Ordonez, JS., et al.[2020]

A novel brain-computer interface (BCI) was developed for late-stage ALS patients, focusing on high-level cognitive processes rather than impaired motor or sensory functions, using EEG-based neurofeedback to self-regulate gamma-oscillations in the superior parietal cortex.

Healthy subjects achieved a decoding accuracy of 70.2% in self-regulating gamma-power, while one completely locked-in ALS patient demonstrated a decoding accuracy of 55.8%, indicating potential for communication despite severe motor impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brain-computer interface based on self-regulation of gamma-oscillations in the superior parietal cortex. Grosse-Wentrup, M., Schölkopf, B.[2014]

Brain-computer interfaces (BCIs) have the potential to significantly enhance the quality of life and autonomy for patients with amyotrophic lateral sclerosis (ALS), but their current use is limited due to technological and user-based challenges, especially in late-stage ALS patients.

Electrophysiological studies reveal neurodegeneration in both motor and non-motor brain regions in ALS, highlighting a critical gap in research for late-stage patients, particularly those in a locked-in state, which could inform the development of more effective BCI systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological correlates of neurodegeneration in motor and non-motor brain regions in amyotrophic lateral sclerosis-implications for brain-computer interfacing. Kellmeyer, P., Grosse-Wentrup, M., Schulze-Bonhage, A., et al.[2019]

The ECOGIW-16E device is a fully implantable, wireless system designed for electrocorticographic (ECoG) recording and cortical stimulation in non-human primates, enhancing safety by eliminating external cables.

This device successfully recorded brain activity and delivered targeted brain stimulation, demonstrating its potential for chronic monitoring and improving procedures for epilepsy treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A fully integrated wireless system for intracranial direct cortical stimulation, real-time electrocorticography data transmission, and smart cage for wireless battery recharge. Piangerelli, M., Ciavarro, M., Paris, A., et al.[2021]

The study successfully demonstrates a method for long-term implantation (6 months) of soft electrocorticography (ECoG) arrays in a minipig model, which is crucial for evaluating the safety and functionality of these devices before human trials.

The research highlights the use of a soft microfabricated electrode array integrated with an MRI-compatible port, allowing for effective monitoring and data acquisition, which could enhance the development of brain-computer interfaces and improve treatment for neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subdural Soft Electrocorticography (ECoG) Array Implantation and Long-Term Cortical Recording in Minipigs. Fallegger, F., Trouillet, A., Lacour, SP.[2023]

A study involving six beagles over a 6-month period demonstrated that subdural electrodes and a fully implantable wireless brain-machine interface (BMI) device showed good biocompatibility with no adverse events or signs of infection.

Histological analysis revealed minimal tissue encapsulation around the electrodes and no significant differences in cell densities of neurons and glial cells, indicating a stable and safe integration of the device with the brain tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal Tissue Reaction after Chronic Subdural Electrode Implantation for Fully Implantable Brain-Machine Interfaces. Yan, T., Kameda, S., Suzuki, K., et al.[2021]

A new wireless neuroprosthesis for electrocorticographic recording was successfully tested in three patients with drug-refractory epilepsy, allowing for prolonged monitoring without the risk of infection associated with traditional wired systems.

The quality of the wireless brain signal transmission was rated as excellent, indicating that this technology could improve the identification of seizure origins and potentially reduce hospital stays and treatment costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wireless Neuroprosthesis for Patients with Drug-refractory Epilepsy: A Proof-of-Concept Study. Romanelli, P., Valiante, TA., Seri, S., et al.[2020]

The brain-computer interface using self-regulation of slow-cortical potentials (SCPs) allowed two late-stage ALS patients to achieve nearly 90% accuracy on simple cognitive tasks, demonstrating their ability to understand instructions and control a cursor with their brain activity.

The method revealed that while both patients struggled with computational tasks, one patient showed significant accuracy decline on short-term memory tasks with delays, indicating potential cognitive challenges that could be monitored over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brain-computer interface tool to assess cognitive functions in completely paralyzed patients with amyotrophic lateral sclerosis. Iversen, IH., Ghanayim, N., Kübler, A., et al.[2009]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03567213

Study Details | NCT03567213 | Investigation on the ... 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.

2. goodday.health goodday.health/trials/3567213

Investigation on the Cortical Communication (CortiCom) System The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03567213?term=neuroport&viewType=Table&checkSpell=&rank=10

Investigation on the Cortical Communication (CortiCom) ... A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be ...

4. policylab.us policylab.us/clinical-trials/l/maryland/condition/amyotrophic-lateral-sclerosis

Amyotrophic Lateral Sclerosis Paid Clinical Trials in Maryland The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an ...

5. blackrockneurotech.com blackrockneurotech.com/insights/blackrock-microsystems-powers-experimental-system-that-enabled-patients-with-paralysis-to-type-fast-and-accurately-in-a-clinical-trial/

Blackrock Microsystems powers experimental system that ... Blackrock Microsystems powers experimental system that enabled patients with paralysis to type fast and accurately in a clinical trial SALT ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03567213

Investigation on the Cortical Communication (CortiCom ... 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 ...

7. policylab.us policylab.us/clinical-trials/l/maryland/baltimore/amyotrophic-lateral-sclerosis

Baltimore, MD Amyotrophic Lateral Sclerosis Paid Clinical Trials ... The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, ...

8. als.net als.net/als-trial-navigator/377/

Trial: Investigation on the Cortical Communication (Corti... This study will directly assess the efficacy of two sources of neural control signals, speech and motor cortex, for BCI control of software and ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03567213?term=AREA%5BConditionSearch%5D(Brain%20Stem%20Infarctions)%20AND%20AREA%5BOverallStatus%5D(RECRUITING)&rank=3

Investigation on the Cortical Communication (CortiCom ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5326682/

Fully Implanted Brain–Computer Interface in a Locked-In ... We describe a method for communication in a patient with late-stage amyotrophic lateral sclerosis (ALS), involving a fully implanted brain– ...