🏛️ Verified NIH Record • Updated 2026-04-14

Functional Outcomes and Control Using Synchron BCI - Canada (NCT07446114)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Synchron, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (18 items).

Location: Sunnybrook Health Sciences Centre — Toronto, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • EXCLUSION CRITERIA:
  • Unrealistic expectations regarding the potential benefits of the device, in the opinion of the Investigator(s).
  • Active infection or unexplained fever in the 48 hours prior to informed consent.
  • Major psychiatric disorder that may adversely impact the participant's safety or study compliance (e.g., severe depression, psychotic features, personality disorder, severe emotional lability, substance abuse), in the opinion of the Investigator(s).
  • Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities, in the opinion of the Investigator(s).
  • Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).
  • Known allergy to patient-contacting materials included in the implanted device (listed in Physician Implant Manual).
  • Contraindication to angiographic imaging or iodine contrast media.
  • History of central venous sinus thrombosis.
  • Recent history of new venous thromboembolic event (in the 6 months prior to implant) or recurrent history of venous thromboembolic disease.
  • Contraindication to antithrombotic therapy, in the opinion of the Investigator(s).
  • Participant is at substantially increased risk of infection, including immunocompromised status, recurrent or chronic infection, or poorly controlled diabetes mellitus.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

  • Sunnybrook Health Sciences Centre — Toronto, Ontario
  • St. Michael's Hospital — Toronto,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗