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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help people with ALS (a disease that affects neurons and weakens muscles) control assistive devices using their minds. The study tests a device called the N1 Implant (also known as the Neuralink N1 Implant or Link) to determine if it can enable participants to operate tools like a robotic arm through thought alone. The aim is to evaluate how well, safely, and consistently the implant functions for this purpose. Individuals who participated in the PRIME Study and already have the N1 Implant might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in assistive technology for ALS.

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 prior data suggests that the N1 Implant is safe for use in controlling assistive devices?

Research has shown that the N1 Implant has been tested in studies with people to assess its safety and effectiveness. In one study, the implant was successfully placed in a participant, who recovered well after surgery. The device is small and wireless, designed to monitor brain activity with tiny sensors.

So far, users of the implant have not reported any major safety issues, suggesting it is generally well-tolerated. However, as this is a new treatment still under study, ongoing research aims to better understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The N1 Implant is unique because it represents a cutting-edge approach to treating ALS by using a brain-computer interface. Unlike standard ALS treatments that focus on managing symptoms or slowing disease progression, the N1 Implant directly translates brain signals into digital commands, potentially allowing patients to communicate more effectively even as mobility declines. Researchers are excited about this treatment because it offers a new avenue for enhancing quality of life and independence for ALS patients by bypassing the need for muscular control entirely.

What evidence suggests that the N1 Implant is effective for ALS?

Research has shown that the N1 Implant, which participants in this trial will receive, helps people with paralysis control assistive devices by picking up signals from brain cells. Early studies on Neuralink's N1 Implant indicated that it successfully detects these signals, allowing users to interact with devices like robotic arms. Recipients of the N1 Implant have used their brain signals to control devices, suggesting it effectively assists those with conditions like ALS. These early results promise to improve the lives of people with severe mobility challenges. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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]

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]

Citations

1. neuralink.com neuralink.com/updates/a-year-of-telepathy/

A Year of Telepathy | Updates Over the past year, three people with paralysis have received Neuralink implants. This blog post explores how each person is using Telepathy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06429735

Precise Robotically IMplanted Brain-Computer InterfacE The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 ...

3. cbc.ca cbc.ca/news/health/neuralink-brain-chip-clinical-trial-1.7626598

Elon Musk's Neuralink brain chip implanted into 2 ... It's the first clinical trial outside the U.S., testing the safety and clinical efficacy of the wireless brain chip.

4. npr.org npr.org/2024/01/30/1227850900/elon-musk-neuralink-implant-clinical-trial

Elon Musk's Neuralink has put in its first human brain implant "Initial results show promising neuron spike detection," he added, referring to the cellular activity between our brains and our nervous systems ...

5. neuralink.com neuralink.com/updates/prime-study-progress-update-second-participant/

PRIME Study Progress Update — Second Participant The surgery, conducted at the Barrow Neurological Institute, went well — Alex was discharged the following day, and his recovery has been smooth ...

6. neuralink.com neuralink.com/updates/prime-study-progress-update/

PRIME Study Progress Update The current version of the device — the N1 Implant — is an intracortical BCI implant designed to record neural activity through 1,024 electrodes ...

7. themiamiproject.org themiamiproject.org/neuralink/

The Miami Project to Cure Paralysis at University of ... Landmark Study Aims to Enable Paralyzed Patients to Use Their Own Thoughts to Control External Devices Through a Brain-Computer Interface.

8. scitrials.org scitrials.org/trial/NCT06700304

Spinal Cord Injury - NCT06700304 This trial aims to test the safety and functionality of a brain implant in people who have severe tetraplegia. The N1 Implant is a small, wireless device ...