Not Yet RecruitingNot Applicable

Functional Outcomes and Control Using Synchron BCI - Australia

Australia10 participantsStarted 2026-04

Plain-language summary

Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)

Age range21 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.
✓. Bilateral upper-limb paresis or Amyotrophic lateral sclerosis (ALS) with bilateral upper limb paresis
✓. The underlying condition causing motor impairment must be refractory to treatment and have been present for a minimum of twelve months.
✓. Aged 21 years or older
✓. Life expectancy greater than 12 months post-implantation
✓. Preserved precentral gyrus assessed using CT
✓. Suitable vascular anatomy assessed using CT venography
✓. Suitable anatomy for subcutaneous pocket creation

✕. Unrealistic expectations regarding the potential benefits of the device.
✕. 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, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.
✕. Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities.
✕. 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
✕. 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 IDNCT07533903

SponsorSynchron, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Senior Director, Clinical Operations

Who can participate

Age range21 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.
✓. Bilateral upper-limb paresis or Amyotrophic lateral sclerosis (ALS) with bilateral upper limb paresis
✓. The underlying condition causing motor impairment must be refractory to treatment and have been present for a minimum of twelve months.
✓. Aged 21 years or older
✓. Life expectancy greater than 12 months post-implantation
✓. Preserved precentral gyrus assessed using CT
✓. Suitable vascular anatomy assessed using CT venography
✓. Suitable anatomy for subcutaneous pocket creation

✕. Unrealistic expectations regarding the potential benefits of the device.
✕. 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, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.
✕. Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities.
✕. 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
✕. Contraindication to angiographic imaging or iodine contrast media.
✕. History of central venous sinus thrombosis.