[BrainConnexion] - Neurodevice Phase I Trial

Study Overview
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Brief Summary
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This study aims to evaluate the safety of a wireless implantable neurodevice microsystem in tetraplegic patients, as well as the efficacy of the electrodes for long-term recording of neural activities and the successful control of an external device.

Detailed Description
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The goal of this study is to develop a miniaturized wireless implantable neurodevice microsystem that records and transmits signals from the motor cortex of tetraplegic patients, bypassing the damaged nervous tissue, to control an external assistive device that restores some form of independence to patients in terms of communication or mobility.

Official Title
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Neurodevice Phase I: Wireless Implantable Neurodevice Microsystem for Neuroprosthesis and Neuroscience

Conditions
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Tetraplegia, Tetraplegia/Tetraparesis, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Locked-in Syndrome, Muscular Dystrophies

Intervention / Treatment
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* Device: BrainConnexion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years old and older Tetraparesis Written informed consent obtained from the patient or legal representative (in the event where the patient is unable to provide consent) prior to entry into the study in accordance with local EC/IRB regulations and/or other application regulations for surrogate consent. Able to perform the pre-operation Brain Computer Interface training as judged by the research team. Exclusion Criteria: Significant medical co-morbidities e.g. cardiac disease Bleeding disorders Any contraindication to surgery Other concomitant intracranial pathologies History of seizures or epilepsy disorder Complications of coagulopathy Surgically unfit Significant psychological issues e.g. Depression Poor psychological support Pregnancy No means of communication Any disease, in the opinion of the Investigator, that is unstable or which could jeopardise the safety of the patient If applicable, psychological assessment may be performed prior to selection as the implantation process will be a long a stressful event, requiring a significant degree of patient cooperation and resilience.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Wireless Implantable Neurodevice Microsystem | Device: BrainConnexion<br>* A 4.4mm by 4.2mm electrode array is placed onto the surface of the motor cortex which is then connected to a miniaturized neural recording microsystem that transmits signals wirelessly to control an external assistive device. Neural signals are recorded at least once every week for 12 months or longer.<br>* Other names: NeuroPort;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of serious adverse events (SAEs) and adverse events (AEs) reported per patient 12 months post-implantation. | The primary objective of this study is to determine the safety of the device. This will be assessed based on the number of SAEs and AEs reported for each patient during the 12 months post-implantation evaluation. This measure will considered a success if the device is not removed for safety reasons within 12-months after implantation. | 6 months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The signal quality of the electrodes for long-term recording of neural signals. | Signal quality will be measured by the number of channels with identifiable single units tracked across each day for 12 months. | Day 1 to Day 365 post-implant | 
| Decoding accuracy per training session. | Decoding accuracy will be measured in percentage (%). | Day 1 to Day 365 post-implant | 
| Number of successful trials per session | The number of successful trials per training session will be measured in percentage (%). | Day 1 to Day 365 post-implant | 
| Time taken to complete each trial per session | This will be measured in seconds (s). | Day 1 to Day 365 post-implant |