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[BrainConnexion] - Neurodevice Phase I Trial

Primary Purpose

Tetraplegia, Tetraplegia/Tetraparesis, Spinal Cord Injuries

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
BrainConnexion
Sponsored by
National Neuroscience Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tetraplegia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  6. History of Epilepsy
  7. Complications of coagulopathy
  8. Surgically unfit
  9. Significant psychological issues e.g. Depression
  10. Poor psychological support
  11. 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.

Sites / Locations

  • National Neuroscience Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

Wireless Implantable Neurodevice Microsystem

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Decoding accuracy per training session.
Decoding accuracy will be measured in percentage (%).
Number of successful trials per session
The number of successful trials per training session will be measured in percentage (%).
Time taken to complete each trial per session
This will be measured in seconds (s).

Full Information

First Posted
December 17, 2018
Last Updated
May 4, 2023
Sponsor
National Neuroscience Institute
Collaborators
Institute of Microelectronics, Institute of Molecular and Cell Biology, Institute for Infocomm Research, Nanyang Technological University
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1. Study Identification

Unique Protocol Identification Number
NCT03811301
Brief Title
[BrainConnexion] - Neurodevice Phase I Trial
Official Title
Neurodevice Phase I: Wireless Implantable Neurodevice Microsystem for Neuroprosthesis and Neuroscience
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
January 27, 2023 (Actual)
Study Completion Date
August 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Neuroscience Institute
Collaborators
Institute of Microelectronics, Institute of Molecular and Cell Biology, Institute for Infocomm Research, Nanyang Technological University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia, Tetraplegia/Tetraparesis, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Locked-in Syndrome, Muscular Dystrophies

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
Wireless Implantable Neurodevice Microsystem
Intervention Type
Device
Intervention Name(s)
BrainConnexion
Other Intervention Name(s)
Neurodevice, NeuroPort
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of serious adverse events (SAEs) and adverse events (AEs) reported per patient 12 months post-implantation.
Description
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 Outcome Measure Information:
Title
The signal quality of the electrodes for long-term recording of neural signals.
Description
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
Title
Decoding accuracy per training session.
Description
Decoding accuracy will be measured in percentage (%).
Time Frame
Day 1 to Day 365 post-implant
Title
Number of successful trials per session
Description
The number of successful trials per training session will be measured in percentage (%).
Time Frame
Day 1 to Day 365 post-implant
Title
Time taken to complete each trial per session
Description
This will be measured in seconds (s).
Time Frame
Day 1 to Day 365 post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Neuroscience Institute
City
Singapore
ZIP/Postal Code
308433
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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[BrainConnexion] - Neurodevice Phase I Trial

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