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Functional Outcomes and Control Using Synchron BCI - Canada | Clinical Trials | Clareo Health

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Functional Outcomes and Control Using Synchron BCI - Canada

NCT07446114•Synchron, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Able to provide informed consent to participate in the study, in the opinion of the Investigator(s).
•2. Diagnosis of amyotrophic lateral sclerosis or motor neuron disease, with bilateral upper-limb paresis.
•3. Aged 18 years or older.
•4. Life expectancy greater than 12 months post-implantation, in the opinion of the Investigator(s).
•5. Preserved precentral gyrus assessed using CT.
•6. Suitable vascular anatomy, in the opinion of the Investigator(s), assessed using CT venography.
•7. Suitable anatomy for subcutaneous pocket creation.
•8. Able to undergo anesthesia.
•9. Willing and able to comply with investigational requirements, including clinical testing visits and training visits in the home.
•10. 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).
+2 more criteria

Exclusion Criteria

•1. Unrealistic expectations regarding the potential benefits of the device, in the opinion of the Investigator(s).
•2. Active infection or unexplained fever in the 48 hours prior to informed consent.
•3. 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).
•4. Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities, in the opinion of the Investigator(s).
•5. Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).
•6. Known allergy to patient-contacting materials included in the implanted device (listed in Physician Implant Manual).
•7. Contraindication to angiographic imaging or iodine contrast media.
•8. History of central venous sinus thrombosis.
•9. Recent history of new venous thromboembolic event (in the 6 months prior to implant) or recurrent history of venous thromboembolic disease.
•10. Contraindication to antithrombotic therapy, in the opinion of the Investigator(s).
+7 more criteria

Locations (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Canada

Key Dates

Start Date

March 1, 2026

Primary Completion Date

December 1, 2026

Completion Date

July 1, 2027

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

Neurologic DisorderALSMotor Neuron Disease

Interventions

Stentrode

DEVICE

Contacts

Jami Smith

CONTACT

323-796-2476 jsmith@synchron.com

Omid Forouzan

CONTACT

323-796-2476

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Functional Outcomes and Control Using Synchron BCI - Canada

Inclusion Criteria

Exclusion Criteria

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