Implanted Synchron BCI to restore digital control for adults with ALS or motor neuron disease

Functional Outcomes and Control Using Synchron BCI - Canada

This project will test whether an implanted Synchron brain-computer interface can help adults with ALS or motor neuron disease who have weakness in both arms control computers and other digital devices.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Synchron, Inc. (Industry-sponsored)
• Locations: 2 sites (Toronto, Ontario and 1 other locations)
• Trial ID: NCT07446114 on ClinicalTrials.gov

What this trial studies

The Synchron BCI motor neuroprosthesis uses an implanted Stentrode and an external transceiver to record voluntary motor-related brain signals and translate them into commands for digital devices. Participants undergo preoperative imaging to confirm preserved sensorimotor cortex and suitable vascular anatomy, followed by surgical implantation, device programming, and training. The protocol combines site visits at Toronto centers with in-home training and testing, with caregivers supporting device use and charging. Outcomes focus on functional device control and daily independence in adults with bilateral upper-limb paresis from ALS or related motor neuron disease.

Who should consider this trial

Good fit: Adults (18+) with a diagnosis of ALS or motor neuron disease who have bilateral upper-limb paresis, preserved precentral gyrus and suitable vascular anatomy on imaging, a life expectancy judged >12 months, ability to undergo anesthesia, English fluency, and caregiver support are the intended candidates.

Not a fit: People without bilateral arm weakness, with very limited life expectancy, unsuitable brain or vascular anatomy for the implant, inability to tolerate anesthesia, or no available caregiver or appropriate home environment are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could restore meaningful control of computers and assistive technologies, increasing day-to-day independence for people with severe arm weakness.

How similar studies have performed: Early clinical work with the same Stentrode BCI has demonstrated feasibility and enabled device control in a small number of participants, but larger studies are needed to confirm broad effectiveness.

Eligibility criteria

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).
11. Patient and Caregiver fluent in English.
12. Suitable home environment for BCI training, including an internet connection.

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).
11. Participant is at substantially increased risk of infection, including immunocompromised status, recurrent or chronic infection, or poorly controlled diabetes mellitus.
12. Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.
13. 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.
14. Pregnant or breast feeding.
15. 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.
16. Patients with ALS due to SOD1 mutations on gene therapy.
17. 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.

Where this trial is running

Toronto, Ontario and 1 other locations

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
• St. Michael's Hospital — Toronto, Canada (Recruiting)

Study contacts

• Study coordinator: Jami Smith

Conditions Neurologic Disorder; ALS; Motor Neuron Disease; BCI; Brain computer interface; MND