Functional Outcomes and Control Using Synchron BCI - Australia

NCT07533903 | Not Yet Recruiting DMC

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

Brief Summary

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

Conditions

Neurologic Disorder; Neurologic Diseases; MND (Motor Neurone DIsease); Motor Neuron Disease; Motor Neuron Disease, Amyotrophic Lateral Sclerosis; Paralysis Arm; Paralysis

Keywords

ALS; BCI; Brain Computer Interface; MND; Upper Limb Paralysis; Motor Neurone 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 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 Outcomes (2)

• 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

Study Arms (1)

Prospective, single-arm, open label study

EXPERIMENTAL

Single Arm

Device: Stentrode

Interventions

Stentrode DEVICE

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

Prospective, single-arm, open label study

Eligibility Criteria

• Age: 21 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.
• Bilateral upper-limb paresis or Amyotrophic lateral sclerosis (ALS) with bilateral upper limb paresis
• The underlying condition causing motor impairment must be refractory to treatment and have been present for a minimum of twelve months.
• Aged 21 years or older
• Life expectancy greater than 12 months post-implantation
• Preserved precentral gyrus assessed using CT
• Suitable vascular anatomy 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.
• 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, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.
• Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities.
• 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
• 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.
• Participant is at substantially increased risk of infection, including immunocompromised status, recurrent 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.
• 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.
• 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.

Sponsors & Collaborators

• Synchron, Inc.: lead

Study Sites (1)

The Royal Melbourne Hospital

Melbourne, Australia

Location

MeSH Terms

Conditions

Nervous System Diseases; Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Paralysis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Senior Director, Clinical Operations

CONTACT

323-796-2476; clinical@synchron.com

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: April 3, 2026
• First Posted: April 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

AU (1)