Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)

Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)

Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)

Study Overview

• Status: Not yet recruiting
• Conditions: Paralysis; Motor Neuron Disease; Neurologic Disorder; Motor Neuron Disease, Amyotrophic Lateral Sclerosis; Neurologic Diseases; MND (Motor Neurone DIsease); Paralysis Arm
• Intervention / Treatment: Device: Stentrode

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Senior Director, Clinical Operations; Phone Number: 323-796-2476; Email: clinical@synchron.com

Study Locations

• Australia
  • Melbourne, Australia
    • The Royal Melbourne Hospital
    • Contact: Kate Furlong, Study Coordinator; Email: kate.furlong2@mh.org.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able to provide informed consent to participate in the study.
2. Bilateral upper-limb paresis or Amyotrophic lateral sclerosis (ALS) with bilateral upper limb paresis
3. The underlying condition causing motor impairment must be refractory to treatment and have been present for a minimum of twelve months.
4. Aged 21 years or older
5. Life expectancy greater than 12 months post-implantation
6. Preserved precentral gyrus assessed using CT
7. Suitable vascular anatomy assessed using CT venography
8. Suitable anatomy for subcutaneous pocket creation
9. Able to undergo anesthesia
10. Willing and able to comply with investigational requirements, including clinical testing visits and training visits in the home.
11. 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)
12. Patient and caregiver fluent in English
13. Suitable home environment for BCI training, including an internet connection

Exclusion Criteria:

1. Unrealistic expectations regarding the potential benefits of the device.
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, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.
4. Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities.
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
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.
11. Participant is at substantially increased risk of infection, including immunocompromised status, recurrent 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. Pregnant or breast feeding.
14. 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.
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective, single-arm, open label study; Single Arm	Device: Stentrode; The Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Device-related serious adverse events resulting in death or permanently increased disability up to 90 days after implant.	3 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
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 days and 365 days after implant	3 Months and 12 Months
Device migration assessed using CT imaging at 90 days and 365 days after implant	3 Months and 12 Months

Other Outcome Measures

Outcome Measure	Time Frame
Time in days from implant to device activation	Number of days from implant to device activation, up to 12 months after implant
Stability of recorded Synchron BCI signal up to 1 year after device implant	12 Months

Collaborators and Investigators

• Sponsor: Synchron, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ALS; Brain Computer Interface; Motor Neurone Disease; BCI; MND; Upper Limb Paralysis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Nervous System Diseases; Paralysis
• Other Study ID Numbers: S-03-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No