[BrainConnexion] - Neurodevice Phase I Trial

Not Applicable

Active, not recruiting

• Conditions: Tetraplegia; Tetraplegia/Tetraparesis; Spinal Cord Injuries; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Locked-in Syndrome; Muscular Dystrophies
• Interventions: Device: BrainConnexion

• Registration Number: NCT03811301
• Lead Sponsor: National Neuroscience Institute

Brief Summary

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

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 Timeline

• Study Start: 2017-11-21
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-22
• Status Verified: 2022-11
• Primary Completion: 2023-01-27
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06
• Study Completion: 2023-08-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	BrainConnexion	Wireless Implantable Neurodevice Microsystem

Primary Outcome Measures

Name	Time	Method
The number of serious adverse events (SAEs) and adverse events (AEs) reported per patient 12 months post-implantation.	6 months post-implant	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Neuroscience Institute; 🇸🇬 Singapore, Singapore