RecruitingNot Applicable

Functional Outcomes and Control Using Synchron BCI - Canada

Canada10 participantsStarted 2026-03-18

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Able to provide informed consent to participate in the study, in the opinion of the Investigator(s).
✓. Diagnosis of amyotrophic lateral sclerosis or motor neuron disease, with bilateral upper-limb paresis.
✓. Aged 18 years or older.
✓. Life expectancy greater than 12 months post-implantation, in the opinion of the Investigator(s).
✓. Preserved precentral gyrus assessed using CT.
✓. Suitable vascular anatomy, in the opinion of the Investigator(s), assessed using CT venography.
✓. Suitable anatomy for subcutaneous pocket creation.
✓. Able to undergo anesthesia.

✕. 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.

Device-related serious adverse events resulting in death or permanently increased disability up to 90 days after implant.

Timeframe: 3 Months

NCT IDNCT07446114

SponsorSynchron, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Jami Smith

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Able to provide informed consent to participate in the study, in the opinion of the Investigator(s).
✓. Diagnosis of amyotrophic lateral sclerosis or motor neuron disease, with bilateral upper-limb paresis.
✓. Aged 18 years or older.
✓. Life expectancy greater than 12 months post-implantation, in the opinion of the Investigator(s).
✓. Preserved precentral gyrus assessed using CT.
✓. Suitable vascular anatomy, in the opinion of the Investigator(s), assessed using CT venography.
✓. Suitable anatomy for subcutaneous pocket creation.
✓. Able to undergo anesthesia.

✕. 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.