[BrainConnexion] - Neurodevice Phase I Trial

National Neuroscience Institute5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

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

Interventions

BrainConnexionDEVICE

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 21 years old and older 2. Tetraparesis 3. 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. 4. Able to perform the pre-operation Brain Computer Interface training as judged by the research team. Exclusion Criteria: 1. Significant medical co-morbidities e.g. cardiac disease 2. Bleeding disorders 3. Any contraindication to surgery 4. Other concomitant intracranial pathologies 5. History of seizures or epilepsy disorder 6. Complications of coagulopathy 7. Surgically unfit 8. Significant psychological issues e.g. Depression 9. Poor psychological support 10. Pregnancy 11. No means of communication 12. 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.

Locations (1)

National Neuroscience Institute

Singapore, Singapore

Outcomes

Primary Outcomes

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.

Time frame: 6 months post-implant

Secondary Outcomes

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.

Time frame: Day 1 to Day 365 post-implant

Decoding accuracy per training session.

Decoding accuracy will be measured in percentage (%).

Time frame: 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 (%).

Time frame: Day 1 to Day 365 post-implant

Time taken to complete each trial per session

This will be measured in seconds (s).

Time frame: Day 1 to Day 365 post-implant

Data from ClinicalTrials.gov

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