Clinical Trials

An early feasibility study of the safety of an endovascular Motor Neuroprosthesis (MNP) in participants with severe upper limb dysfunction

Type of Study/Intervention

Device

Recruitment Status

Recruiting

Form of MS

Relapsing remitting MS, Relapsing MS, Secondary progressive MS, Primary progressive MS, Clinically isolated syndrome, People without MS

Brief summary

The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe upper limb 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.

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/caregiver

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. Unable to provide evidence of COVID vaccination
9. No study partner/caregiver

Anticipated start date

June 2022

Recruitment contacts

VIC: Melissa Ugalde, Royal Melbourne Hospital, melissa.ugalde@mh.org.au

QLD: Kathryn Anne Thorpe, Royal Brisbane and Womens Hospital, kathryn.thorpe@health.qld.gov.au

NSW: Not yet recruiting

Further details

Full details of the trial can be found on clinicaltrials.gov.

Region

VIC, QLD

Ethics approval

Yes

Last updated

21/06/2022

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