Amyotrophic Lateral Sclerosis, Muscular Dystrophies, Neurologic Disorder, Paralysis, Paralysis; Stroke, Spinal Cord Injury, Spinal Muscular Atrophy, Stroke, Brainstem, Stroke, Lacunar, Upper Limb Injury
Conditions
Brief summary
The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility. The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.
Interventions
DEVICEMotor Neuroprosthesis
Type of implantable brain computer interface
Sponsors
Synchron Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Severe motor impairment 2. Able to give consent 3. Appropriate candidate for neurointerventional procedure 4. Able and willing to access all clinical testing and not impeded by geographical location 5. Proficient in English 6. Have a study partner
Exclusion criteria
1. Active condition resulting in immunosuppression 2. Unsuitable for general anaesthetic 3. Anaphylactic allergy to contrast media 4. Allergy to nickel 5. History of pulmonary embolism 6. History of recent deep vein thrombosis 7. Psychiatric or psychological disorder 8. No study partner or caregiver 9. Unable to provide evidence of COVID vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment related adverse events | 12 months post implant |
Countries
Australia
Outcome results
None listed