RecruitingNot Applicable

Functional Outcomes and Control Using Synchron BCI - Australia

Australia10 participantsStarted 2026-05-22

Plain-language summary

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

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 3 Months

Trial details

NCT IDNCT07533903

SponsorSynchron, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Senior Director, Clinical Operations

323-796-2476 clinical@synchron.com

View on ClinicalTrials.gov More Neurologic Disorder trials