10 Participants NeededMy employer runs this trial

Stentrode for Lou Gehrig's Disease

(FOCUS-CAN Trial)

Recruiting at 1 trial location
JS
OF
Overseen ByOmid Forouzan
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 aims to test a device called the Stentrode, which might help people with Lou Gehrig's Disease (ALS) regain control over daily activities using a brain-computer interface. The study seeks individuals diagnosed with ALS or motor neuron disease who have significant weakness in both arms. Those who have had ALS for a while and face challenges using their arms may find this trial suitable. Participants need a supportive home environment and a caregiver to assist with study visits and device use. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve the quality of life for ALS patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on treatments that might interfere with the device implant, such as certain imaging or therapies, you may need to discuss this with the study team.

What prior data suggests that this device is safe for use in Lou Gehrig's Disease?

Research has shown that the Stentrode device is generally safe for people with Lou Gehrig's disease (ALS). In a study with six ALS patients, researchers found the Stentrode to be safe, with no serious problems reported. Specifically, there were no major issues like severe injuries or life-threatening situations. Another study followed participants for a year and found the device did not cause disability or death. These findings suggest that patients tolerate the Stentrode well and it does not cause severe side effects.12345

Why are researchers excited about this trial?

Unlike traditional treatments for Lou Gehrig's Disease (ALS), which often include medications to manage symptoms and slow disease progression, the Stentrode offers a groundbreaking approach. The Stentrode is a tiny brain implant designed to help patients control external devices using their thoughts, potentially improving communication and mobility. Researchers are excited because this device taps into the brain's signals without invasive surgery, using blood vessels as a natural pathway. This novel delivery method could significantly enhance the quality of life for ALS patients, offering a new level of independence.

What evidence suggests that the Stentrode is effective for Lou Gehrig's Disease?

Research has shown that the Stentrode, a device connecting the brain to a computer, may assist people with Lou Gehrig's disease, also known as ALS. In previous studies, four patients with ALS used the Stentrode to complete online tasks solely through thought. This suggests the device might enable them to communicate and interact with the world again. Importantly, no serious side effects occurred, indicating it as a safe option. While these results are promising, the current trial will further investigate its effectiveness and safety in a larger group of patients.25678

Are You a Good Fit for This Trial?

This trial is for adults (18+) with ALS or motor neuron disease who have significant weakness in both arms. Participants need a caregiver, must be able to undergo anesthesia, have suitable blood vessels and brain anatomy, speak English, live in a home with internet access, and be expected to live at least 12 months.

Inclusion Criteria

Caregiver(s) willing and able to facilitate study visits, including visits at the study site and in the home, and BCI use outside of study visits (e.g., device charging)
Preserved precentral gyrus assessed using CT
Life expectancy greater than 12 months post-implantation, in the opinion of the Investigator(s)
See 9 more

Exclusion Criteria

Known allergy to patient-contacting materials included in the implanted device (listed in Physician Implant Manual)
I have had a blood clot in the veins of my brain.
I have had a new or repeated blood clot in the past 6 months.
See 14 more

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 device

1 week

Treatment

Participants use the Synchron BCI to control digital devices, aiming to improve functional independence

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Stentrode

Trial Overview

The study tests the Stentrode brain-computer interface (BCI), an implanted device that helps people with severe paralysis control digital devices using their thoughts. The trial will monitor how well participants can use the BCI at home and any effects on daily function.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SingleExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Synchron, Inc.

Lead Sponsor

Citations

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.

AAN2022 – Stentrode Enables Tasks With 'Just a Thought'

Synchron's Stentrode, an innovative, implantable brain computer interface (BCI), was found safe in four amyotrophic lateral sclerosis (ALS) patients.

3.

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.

Mayo Clinic builds on breakthrough discoveries to advance ...

ALS, also known as motor neuron disease and Lou Gehrig's disease, affects nerves, leading to progressive weakness and loss of movement.

Stentrode for Lou Gehrig's Disease (FOCUS-CAN Trial)

The FOCUS-CAN medical study, being run by Synchron, Inc., is evaluating whether Stentrode will have tolerable side effects & efficacy for ...

Advancements in the application of brain-computer interfaces ...

The introduction of this innovative ECoG-based BCI provides a more convenient, efficient, and user-friendly communication method for individuals with severe ALS ...

Synchron Announces Positive Results From Stentrode BCI ...

After announcing positive results showing that its Stentrode BCI is safe in six patients, brain-computer interface company Synchron is planning a pivotal trial.

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, ...