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Recruiting NCT07533903

Functional Outcomes and Control Using Synchron BCI - Australia

No phase Interventional Neurologic Disorder Neurologic Diseases MND (Motor Neurone DIsease) Motor Neuron Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stentrode.
Who it may be relevant to
Registry conditions: Neurologic Disorder, Neurologic Diseases, MND (Motor Neurone DIsease), Motor Neuron Disease. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

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

Primary outcome measures

  • Device-related serious adverse events resulting in death or permanently increased disability up to 90 days after implant. [Time frame: 3 Months]
Secondary outcome measures (3)
  • Device-related serious adverse events resulting in death or permanently increased disability up to 1 year after implant. [Time frame: 12 Months]
  • Target vessel patency assessed using CT venography at 90 days and 365 days after implant [Time frame: 3 Months and 12 Months]
  • Device migration assessed using CT imaging at 90 days and 365 days after implant [Time frame: 3 Months and 12 Months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Australia · 1 center
  • The Royal Melbourne Hospital — Melbourne

Identifiers

NCT: NCT07533903 · S-03-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗