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

Trial Summary

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 data supports the effectiveness of the treatment CortiCom System, CortiCom System, Platinum PMT Subdural Cortical Electrode Grids, Blackrock Microsystems Patient Pedestal, NeuroPort Neural Signal Processor for ALS?

Research shows that brain-computer interfaces (BCIs) can help improve communication for people with late-stage ALS, even though current systems face challenges in performance and user adoption. The CortiCom System and related components are part of this BCI technology, which aims to enhance the quality of life for ALS patients by enabling communication. ^{1 2 3 4 5}

What safety data exists for the Brain-Computer Interface used in ALS clinical trials?

Research on similar devices, like subdural electrodes and wireless brain-machine interfaces, shows minimal tissue reaction and no adverse events in animal studies over six months. These devices have been tested for safety and biocompatibility, indicating they can be safely maintained in the body for extended periods. ^{6 7 8 9 10}

How does the CortiCom System treatment for ALS differ from other treatments?

The CortiCom System is a unique brain-computer interface (BCI) that allows patients with late-stage ALS to communicate using high-level cognitive processes, rather than relying on motor or sensory functions that are often impaired. This system is designed for long-term use and can be used at home, offering a novel way to improve communication for those who have lost voluntary control. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Nathan E Crone, MD

Principal Investigator

Professor of Neurology

Eligibility Criteria

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.

I am not on long-term steroids or drugs that weaken my immune system.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Stability of a chronic implanted brain-computer interface in late-stage amyotrophic lateral sclerosis. [2020]

2. England 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. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

A brain-computer interface tool to assess cognitive functions in completely paralyzed patients with amyotrophic lateral sclerosis. [2009]

5. England pubmed.ncbi.nlm.nih.gov

A brain-computer interface based on self-regulation of gamma-oscillations in the superior parietal cortex. [2014]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Minimal Tissue Reaction after Chronic Subdural Electrode Implantation for Fully Implantable Brain-Machine Interfaces. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Hermetic electronic packaging of an implantable brain-machine-interface with transcutaneous optical data communication. [2020]

8. Switzerland 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A Wireless Neuroprosthesis for Patients with Drug-refractory Epilepsy: A Proof-of-Concept Study. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Subdural Soft Electrocorticography (ECoG) Array Implantation and Long-Term Cortical Recording in Minipigs. [2023]