Functional Outcomes and Control Using Synchron BCI - Canada

NCT07446114 | Recruiting DMC

• 1 other identifier: S-03-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Neurologic Disorder; ALS; Motor Neuron Disease

Keywords

ALS; BCI; Brain computer interface; MND; Motor Neuron Disease

Outcome Measures

Primary Outcomes (1)

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

  3 Months

Secondary Outcomes (3)

• Device-related serious adverse events resulting in death or permanently increased disability up to 1 year after implant.

  12 Months

• Target vessel patency assessed using CT venography at 90 and 365 days after implant.

  3 Months and 12 Months

• Device migration assessed using CT venography at 90 and 365 days after implant.

  3 Months and 12 Months

Other Outcomes (2)

• Time in days from implant to device activation.

  Number of days from device implant to device activation, up to 12 months after implant.

• Stability of recorded BCI signal, using monthly measurements up to 1 year after device implant.

  12 Months

Study Arms (1)

Single

OTHER

Single Arm

Device: Stentrode

Interventions

Stentrode DEVICE

The Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.

Single

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Synchron, Inc.: lead

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M5C 1N2, Canada

RECRUITING

St. Michael's Hospital

Toronto, M5C 1R6, Canada

RECRUITING

MeSH Terms

Conditions

Nervous System Diseases; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Neuromuscular Diseases

Central Study Contacts

Jami Smith

CONTACT

323-796-2476; jsmith@synchron.com

Omid Forouzan

CONTACT

323-796-2476

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Insertion of Stentrode Device

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: March 3, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)