Neurologic DisorderFOCUS-AUSNCT07533903
Functional Outcomes and Control Using Synchron BCI - Australia
A study testing Stentrode in people with Neurologic Disorder and Neurologic Diseases, run by Synchron, Inc. at 1 site in Australia.
Trial summary
Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS) Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Neurologic Disorder, Neurologic Diseases, MND (Motor Neurone DIsease)
- What is being tested?
- Stentrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 22 May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Suitable vascular anatomy assessed using CT venography
- Suitable anatomy for subcutaneous pocket creation
- Able to undergo anesthesia
- Willing and able to comply with investigational requirements, including clinical testing visits and training visits in the home.
- 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)
- Patient and caregiver fluent in English
- Suitable home environment for BCI training, including an internet connection
Who cannot join
- 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
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- 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.
- Participant is at substantially increased risk of infection, including immunocompromised status, recurrent infection, or poorly controlled diabetes mellitus.
- Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.
- Pregnant or breast feeding.
- Patients who are currently enrolled in any other clinical trial that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements.
- Any other disease or disorder that could significantly affect participation in the study. Examples may include corrected vision insufficient for viewing computer screens or hearing insufficient for following verbal instructions, which might impact the participant's ability to participate in BCI training and testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
The Royal Melbourne Hospital
Melbourne
Kate Furlong, Study Coordinator, kate.furlong2@mh.org.au
Prof Peter Mitchell, MD, peter.mitchell@mh.org.au
About this study
Official title: Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)
Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)
Read the detailed description
The Synchron BCI motor neuroprosthesis is an implanted brain-computer interface indicated for adults with bilateral upper-limb motor impairment. The Synchron BCI is intended to replace the function of motor neurons by detecting, translating and transmitting motor-related brain signals to restore clinically meaningful control of digital devices.
- Conditions
- Neurologic Disorder, Neurologic Diseases, MND (Motor Neurone DIsease), Motor Neuron Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Paralysis Arm
- Being tested
- Stentrode
- Keywords
- ALS, BCI, Brain Computer Interface, MND, Upper Limb Paralysis, Motor Neurone Disease
- Medical subject headings
- Nervous System Diseases, Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentrodeDevice
The Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.
| Study group | Role | What they receive |
|---|---|---|
| Prospective, single-arm, open label study | Experimental | Single Arm Receives: Device: Stentrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related serious adverse events resulting in death or permanently increased disability up to 90 days after implant.
Measured: 3 Months
Secondary outcomes (3)
Device-related serious adverse events resulting in death or permanently increased disability up to 1 year after implant.
Measured: 12 Months
Target vessel patency assessed using CT venography at 90 days and 365 days after implant
Measured: 3 Months and 12 Months
Device migration assessed using CT imaging at 90 days and 365 days after implant
Measured: 3 Months and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start22 May 2026
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Insertion of Stentrode Device
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synchron, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533903
- Sponsor's protocol ID
- S-03-03
- Acronym
- FOCUS-AUS
- Status last verified
- Jun 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)
- ClinicalTrials.gov ID
- NCT07533903
- Acronym / sponsor ID
- FOCUS-AUS / S-03-03
- Conditions
- Neurologic Disorder, Neurologic Diseases, MND (Motor Neurone DIsease), Motor Neuron Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Paralysis Arm
- Keywords
- ALS, BCI, Brain Computer Interface, MND, Upper Limb Paralysis, Motor Neurone Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Synchron, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 May 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)
Detailed description
The Synchron BCI motor neuroprosthesis is an implanted brain-computer interface indicated for adults with bilateral upper-limb motor impairment. The Synchron BCI is intended to replace the function of motor neurons by detecting, translating and transmitting motor-related brain signals to restore clinically meaningful control of digital devices.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Insertion of Stentrode Device
| Arm | Type | Receives |
|---|---|---|
| Prospective, single-arm, open label study | Experimental | Device: StentrodeSingle Arm |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StentrodeThe Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices. | Device | Prospective, single-arm, open label study |
Primary outcome
Device-related serious adverse events resulting in death or permanently increased disability up to 90 days after implant.
Time frame: 3 Months
3 secondary outcomes
Device-related serious adverse events resulting in death or permanently increased disability up to 1 year after implant.
Time frame: 12 Months
Target vessel patency assessed using CT venography at 90 days and 365 days after implant
Time frame: 3 Months and 12 Months
Device migration assessed using CT imaging at 90 days and 365 days after implant
Time frame: 3 Months and 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stentrode in people with Neurologic Disorder and Neurologic Diseases, run by Synchron, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senior Director, Clinical Operations (323-796-2476, clinical@synchron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-related serious adverse events resulting in death or permanently increased disability up to 90 days after implant. (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.