Stentrode for Lou Gehrig's Disease

(FOCUS-CAN Trial)

Recruiting at 1 trial location

Overseen By Jami Smith

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Synchron, Inc.

Must not be taking: Antithrombotics

Disqualifiers: Major psychiatric disorder, Dementia, Active implanted device, Infection risk, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN)

Are You a Good Fit for This Trial?

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)

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.

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

How Is the Trial Designed?

Group I: Single Experimental Treatment 1 Intervention

Single Arm

Who Is Running the Clinical Trial?

Synchron, Inc.

Lead Sponsor