10 Participants NeededMy employer runs this trial

Stentrode for ALS

Recruiting at 4 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called Stentrode to assist people with ALS, a nervous system disease that weakens muscles. The goal is to determine if Stentrode can improve independence for those who have had ALS for more than six months and experience weakness in both arms. Suitable candidates have ALS that hasn't improved with other treatments and can manage daily life with caregiver assistance. Individuals fitting this description and able to attend regular study visits might consider this trial. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for ALS patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for ALS patients?

Research has shown that the Stentrode device is generally safe for humans. In one study, researchers observed participants for a year and found no serious problems leading to disability or death. Another study reported no major side effects, though some mild ones occurred. The device also meets FDA safety standards for other uses. Overall, studies indicate that the Stentrode is usually well-tolerated.12345

Why are researchers excited about this trial?

The Stentrode is unique because it offers a new way to help people with ALS by using a brain-computer interface. Unlike other treatments that focus on slowing disease progression with medications like Riluzole or Edaravone, the Stentrode is a small device that's implanted in a blood vessel in the brain, allowing patients to control digital devices with their thoughts. This innovative approach aims to improve communication and quality of life for those with ALS, and researchers are excited because it represents a potential breakthrough in assistive technology for neurodegenerative diseases.

What evidence suggests that the Stentrode is effective for ALS?

Research has shown that the Stentrode device, a brain-computer interface, could benefit people with ALS (amyotrophic lateral sclerosis). Studies have found that it functions effectively without causing serious side effects. In this trial, participants will receive the Stentrode device, which might enhance the quality of life for patients with paralysis by enabling them to use technology through thought. While the main focus has been on safety and efficacy, these findings suggest it could help manage ALS symptoms. However, further research is needed to confirm its effectiveness in treating ALS specifically.16789

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with ALS who have weakness in both arms, have had the disease for at least six months, and are not responding to treatment. Participants must be able to undergo anesthesia, attend study visits, give consent, and have suitable brain and blood vessel anatomy.

Inclusion Criteria

* Preserved precentral gyrus assessed using CT.
* Suitable vascular anatomy assessed using CT venography.
I have ALS and weakness in both of my arms.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Participants undergo implantation of the Synchron BCI motor neuroprosthesis

1 week
1 visit (in-person)

Treatment

Participants use the implanted device to control digital devices, with ongoing monitoring and adjustments

12 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Stentrode

Trial Overview

The study is testing a device called Stentrode—a small implant placed in the brain's blood vessels—to help people with ALS control digital devices using their thoughts. This early feasibility study will assess safety and how well it works.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Synchron, Inc.

Lead Sponsor

Citations

Stem Cell Therapy for the Treatment of Amyotrophic Lateral ...

Upon administering these modified cells to hSOD1G93A ALS model mice, they observed enhanced motor performance and prolonged survival, suggesting ...

Efficacy of Stem Cell Therapy in Amyotrophic Lateral Sclerosis

Published studies seeking to improve survival in amyotrophic lateral sclerosis (ALS) have poor results in humans, although there are several studies in animal ...

Synchron announces long-term safety results with ...

Researchers monitored participants for one year and found the device to be safe, with no serious adverse events that led to disability or death.

2021 Spinal Cord Injury Highlight - Stentrode: A SCIRP- ...

By the close of the SCIRP award, the Stentrode achieved Food and Drug Administration (FDA)-required benchmarks,2 including those for safety and ...

Synchron reports positive results from Command study ...

The Command study showed reliable performance of Synchron's Stentrode brain-computer interface implant and no serious adverse events.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36622685/

Assessment of Safety of a Fully Implanted Endovascular Brain ...

These final safety and feasibility data from the first in-human SWITCH study indicate that it is possible to record neural signals from a blood vessel.

Assessment of Safety of a Fully Implanted Endovascular ...

This case series assesses the safety of an endovascular brain-computer interface and feasibility of using the system to control a computer ...

Stentrode Device Allows 4 Paralyzed ALS Patients to Use ...

Results were positive, with no serious side effects related to the device reported in any of the patients. Some mild side effects occurred, such ...

Synchron's brain-computer interface implant deemed safe ...

One year after the device's placement, none of the four participants had experienced any adverse events that led to disability or death.