Brain-Computer Interface for ALS

(CONVOY Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Neuralink Corp

Disqualifiers: Explantation, Deactivation, Insufficient performance, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

3 Participants Needed

Trial Summary

What is the purpose of this trial?

The CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices. The main goal is to determine whether participants can successfully modulate their brain activity to control devices, such as an Assistive Robotic Arm (ARA). This study will assess the effectiveness, consistency, and safety of neural control using the ARA and other assistive devices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Neuralink N1 Implant treatment for ALS?

Research shows that brain-computer interfaces (BCIs) can help people with ALS communicate by using neural signals to control devices, even when other technologies fail. Studies have demonstrated that implanted BCIs can reliably enable communication and control of assistive devices over long periods, with high accuracy and without needing frequent recalibration. ^{1 2 3 4 5}

Is the Neuralink N1 Implant safe for humans?

The safety of brain-computer interfaces (BCIs), like the Neuralink N1 Implant, is still being studied. The BrainGate feasibility study, which is the largest and longest-running clinical trial of an implanted BCI, is investigating the safety of these devices in humans, but conclusive safety data is not yet available. ^{3 4 6 7 8}

How is the N1 Implant treatment different from other treatments for ALS?

The N1 Implant is unique because it is a brain-computer interface (BCI) that allows people with ALS to communicate by interpreting brain signals, even when they can't move or speak. Unlike other communication aids that require some motor function, this implant uses electrodes placed on the brain to decode intended movements or speech, enabling communication through thought alone. ^{1 3 4 5 9}

Eligibility Criteria

This trial is for individuals with severe mobility impairments due to conditions like quadriplegia, spinal cord injury, or ALS. Participants should have previously been part of the PRIME Study and are now looking to test controlling assistive devices using their brain activity.

Inclusion Criteria

Continued enrollment in the PRIME Study

Implanted with the N1 Implant

Exclusion Criteria

Explantation or deactivation of the N1 Implant

Insufficient N1 Implant BCI performance demonstrated

Lack of a suitable physical space to perform research sessions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the N1 Implant to control assistive devices, such as an Assistive Robotic Arm (ARA), to assess effectiveness, consistency, and safety of neural control

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• N1 Implant

Trial Overview The CONVOY Study tests if participants can use the N1 Implant from a prior study to control an Assistive Robotic Arm (ARA) and other devices by modulating brain activity. It aims to evaluate how effective, consistent, and safe this neural control is.

Participant Groups

Group I: Single Experimental Treatment 1 Intervention

N1 Implant is already approved in United States, Canada for the following indications:

Approved in United States as Neuralink N1 Implant for:

• Quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS)

Approved in Canada as Neuralink N1 Implant for:

• Tetraparesis or tetraplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS)

Who Is Running the Clinical Trial?

Neuralink Corp

Lead Sponsor

Trials

3

Recruited

10+

Findings from Research

The Wadsworth brain-computer interface (BCI) was successfully used by 14 out of 27 patients with advanced ALS for independent communication at home, demonstrating its reliability and usefulness over an 18-month period.

Despite some patients leaving the study due to disease progression or decreased interest, the majority of users found the BCI beneficial for communication, with minimal technical issues and stable quality of life reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Independent home use of a brain-computer interface by people with amyotrophic lateral sclerosis. Wolpaw, JR., Bedlack, RS., Reda, DJ., et al.[2023]

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]

The BrainGate feasibility study, involving 14 adults with quadriparesis, demonstrated that the implanted microelectrode arrays had a low rate of serious adverse events (SAEs) over an average implantation duration of 872 days, with no device-related deaths or permanent disabilities.

The most common adverse event was skin irritation, and overall, the safety profile of the BrainGate Neural Interface system is comparable to other chronically implanted medical devices, suggesting a favorable risk/benefit ratio for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. Rubin, DB., Ajiboye, AB., Barefoot, L., et al.[2023]

A large-scale survey of 1918 ALS patients revealed that 77% were interested in brain-machine interfaces (BMIs), with over 60% expressing expectations for various communication and movement supports.

Patients with tracheostomy had high expectations for communication and emergency alarms from BMIs, while those without tracheostomy showed greater interest in movement supports, highlighting the need for tailored BMI solutions based on patient status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nationwide survey of 780 Japanese patients with amyotrophic lateral sclerosis: their status and expectations from brain-machine interfaces. Kageyama, Y., He, X., Shimokawa, T., et al.[2021]

Patients with ALS who have behavioral impairments are less receptive to using brain-computer interfaces (BCIs) for communication, indicating that cognitive and behavioral factors significantly affect acceptance of this technology.

A pilot study revealed that patients' experiences with operating a BCI influenced their opinions on its usefulness, suggesting that user experience should be a key consideration in the design and implementation of assistive devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance of brain-computer interfaces in amyotrophic lateral sclerosis. Geronimo, A., Stephens, HE., Schiff, SJ., et al.[2015]

References

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

Independent home use of a brain-computer interface by people with amyotrophic lateral sclerosis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Amyotrophic lateral sclerosis progression and stability of brain-computer interface communication. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

Towards clinical application of implantable brain-computer interfaces for people with late-stage ALS: medical and ethical considerations. [2023]

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

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

5. Germany pubmed.ncbi.nlm.nih.gov

Stable Decoding from a Speech BCI Enables Control for an Individual with ALS without Recalibration for 3 Months. [2023]

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

Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Nationwide survey of 780 Japanese patients with amyotrophic lateral sclerosis: their status and expectations from brain-machine interfaces. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Acceptance of brain-computer interfaces in amyotrophic lateral sclerosis. [2015]

9. Japan pubmed.ncbi.nlm.nih.gov

[Communication with ALS patients: neurosurgical approach]. [2019]