Neurologic DisorderFOCUS-CANNCT07446114
Functional Outcomes and Control Using Synchron BCI - Canada
A study testing Stentrode in people with Neurologic Disorder and ALS, run by Synchron, Inc. at 2 sites in Canada.
Trial summary
Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Disorder, ALS, Motor Neuron 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
- 2 sitesCanada
- Study dates
- 18 Mar 2026to Jul 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 18 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, 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.
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- 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, 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).
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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, 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.
- Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.
- Currently receiving or expected to require medical treatment that may be precluded by device implant, including magnetic resonance imaging, transcranial magnetic stimulation, electroconvulsive therapy, transcranial ultrasound, shortwave, microwave, and/or therapeutic ultrasound diathermy, or balloon angioplasty or stenting in the target vessel.
- 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.
- Patients with ALS due to SOD1 mutations on gene therapy.
- Any other disease or disorder that could significantly affect participation in the study, in the opinion of the Investigator(s). 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Omid Forouzan contact
Canada2 sites, 2 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M5C 1N2
Jahan Mookshah, +1 416-480-6100 ext. Ext. 687561, jahan.mookshah@sunnybrook.ca
Lorne Zinman, MD
- Recruiting
St. Michael's Hospital
Toronto, M5C 1R6
Eileen Liu
Vitor Pereira, MD
About this study
Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN)
Read the detailed description
Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN):
The Synchron BCI motor neuroprosthesis is an implanted brain-computer interface indicated for adults with bilateral upper-limb motor impairment, including Motor Neuron Disease. 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.
The Synchron BCI is an implanted BCI device that interfaces with the brain to enable control of digital devices in individuals with bilateral upper-limb motor impairment. The Synchron BCI is designed to record volitional motor-related neural signals from the sensorimotor cortices and translate these signals into digital motor outputs to enable control of digital devices to improve functional independence. The system includes both implantable and non-implantable components. Implantable components are the Stentrode and the Transceiver.
- Conditions
- Neurologic Disorder, ALS, Motor Neuron Disease
- Being tested
- Stentrode
- Keywords
- ALS, BCI, Brain computer interface, MND, Motor Neuron Disease
- Medical subject headings
- Nervous System Diseases, Motor Neuron Disease
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 |
|---|---|---|
| Single | Other | 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 and 365 days after implant.
Measured: 3 Months and 12 Months
Device migration assessed using CT venography at 90 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 posted3 Mar 2026
- Study start18 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionJul 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
- NCT07446114
- Sponsor's protocol ID
- S-03-01
- Acronym
- FOCUS-CAN
- Status last verified
- Apr 2026
- First submitted
- 26 Jan 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes and Control Using Synchron BCI - Canada
- ClinicalTrials.gov ID
- NCT07446114
- Acronym / sponsor ID
- FOCUS-CAN / S-03-01
- Conditions
- Neurologic Disorder, ALS, Motor Neuron Disease
- Keywords
- ALS, BCI, Brain computer interface, MND, Motor Neuron Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Synchron, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Mar 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 - Canada (FOCUS-CAN)
Detailed description
Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN):
The Synchron BCI motor neuroprosthesis is an implanted brain-computer interface indicated for adults with bilateral upper-limb motor impairment, including Motor Neuron Disease. 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.
The Synchron BCI is an implanted BCI device that interfaces with the brain to enable control of digital devices in individuals with bilateral upper-limb motor impairment. The Synchron BCI is designed to record volitional motor-related neural signals from the sensorimotor cortices and translate these signals into digital motor outputs to enable control of digital devices to improve functional independence. The system includes both implantable and non-implantable components. Implantable components are the Stentrode and the Transceiver.
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 |
|---|---|---|
| Single | Other | Device: StentrodeSingle Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.).
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 | Single |
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 and 365 days after implant.
Time frame: 3 Months and 12 Months
Device migration assessed using CT venography at 90 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 17 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Omid Forouzan contact
2 sites 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 ALS, run by Synchron, Inc. at 2 sites in Canada.
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 12 inclusion and 17 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 Jami Smith (323-796-2476, jsmith@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 17 Apr 2026.