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[BrainConnexion] - Neurodevice Phase II Trial

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ClinicalTrials.gov Identifier: NCT03811301
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : January 21, 2019
Sponsor:
Collaborators:
Institute of Microelectronics
Institute of Molecular and Cell Biology
Institute for Infocomm Research
Nanyang Technological University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tetraplegia Tetraplegia/Tetraparesis Spinal Cord Injuries Amyotrophic Lateral Sclerosis Motor Neuron Disease Locked-in Syndrome Muscular Dystrophies Device: BrainConnexion Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neurodevice Phase II: Wireless Implantable Neurodevice Microsystem for Neuroprosthesis and Neuroscience
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: Interventional
Wireless Implantable Neurodevice Microsystem
Device: BrainConnexion
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.
Other Names:
  • Neurodevice
  • NeuroPort




Primary Outcome Measures :
  1. The number of serious adverse events (SAEs) and adverse events (AEs) reported per patient 12 months post-implantation. [ Time Frame: 12 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 :
  1. The signal quality of the electrodes for long-term recording of neural signals. [ Time Frame: 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.

  2. Decoding accuracy per training session. [ Time Frame: Day 1 to Day 365 post-implant ]
    Decoding accuracy will be measured in percentage (%).

  3. Number of successful trials per session [ Time Frame: Day 1 to Day 365 post-implant ]
    The number of successful trials per training session will be measured in percentage (%).

  4. Time taken to complete each trial per session [ Time Frame: Day 1 to Day 365 post-implant ]
    This will be measured in seconds (s).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811301


Contacts
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Contact: Wai Hoe Ng, MD, FRACS (65) 6357 7157 ng.wai.hoe@singhealth.com.sg

Locations
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Singapore
National Neuroscience Institute Recruiting
Singapore, Singapore, 308433
Contact: Wai Hoe Ng, MD, FRACS    (65) 6357 7506    ng.wai.hoe@singhealth.com.sg   
Principal Investigator: Wai Hoe Ng, MD, FRACS         
Sub-Investigator: Rosa So         
Sub-Investigator: Yuan Gao         
Sub-Investigator: Kai Keng Ang         
Sub-Investigator: Jai Rao         
Sub-Investigator: Karen Chua         
Sub-Investigator: Brian Premchand         
Sub-Investigator: Juanhong Yu         
Sub-Investigator: Huijuan Yang         
Sub-Investigator: Tao Yang         
Sub-Investigator: Kyaw Kyar Toe         
Sub-Investigator: Kok Soon Phua         
Sub-Investigator: Thevapriya Selvaratnam         
Sub-Investigator: Valerie E Toh         
Sponsors and Collaborators
National Neuroscience Institute
Institute of Microelectronics
Institute of Molecular and Cell Biology
Institute for Infocomm Research
Nanyang Technological University

Publications:
Lee, K., Singh, A., He, J., Massia, S., Kim, B., & Raupp, G. (2004). Polyimide based neural implants with stiffness improvement. Sensors Actuators B Chem,102(1), 67-72. doi: 10.1016/j.snb.2003.10.018.
Cheng, M. Y., Je, M., Tan, K. L., et al. (2013). A low-profile three-dimensional neural probe array using a silicon lead transfer structure. J Micromechanics Microengineering, 23(9), 095013. doi:10.1088/0960-1317/23/9/095013.
Cheng, M. Y., Yao, L., Tan, K. L., Lim, R., Li, P., & Chen, W. (2014). 3D probe array integrated with a front-end 100-channel neural recording ASIC. J Micromechanics Microengineering, 24(12), 125010. doi:10.1088/0960-1317/24/12/125010.
Zou, X., Liu, L., Cheong, J. H., et al. (2013). A 100-Channel 1-mW implantable neural recording IC. IEEE Trans Circuits Syst I Regul Pap, 60(10), 2584-2596. doi:10.1109/TCSI.2013.2249175.
Christopher and Dana Reeve Foundation. Christopher and Dana Reeve Foundation. https://www.christopherreeve.org/. Published 2016.
Technical specifications for short range devices - Issue 1 Rev 7, Apr 2013. https://www.ida.gov.sg/~/media/Files/PCDG/Licensees/StandardsQoS/RadiocomEquipStd/TSSRD.pdf
Liu X, Zhou J, Wang C, et al. An Ultralow-Voltage Sensor Node Processor With Diverse Hardware Acceleration and Cognitive Sampling for Intelligent Sensing. IEEE Trans Circuits Syst II Express Briefs. 2015;62(12):1149-1153. doi:10.1109/TCSII.2015.2468927.
So RQ, Xu Z, Libedinsky C., Ang KK, Toe KK, Yen SC, Guan CT (2015) Neural Representations of Movement during Brain-Controlled Self-Motion. Conf Proc 7th International IEEE EMBS Conference on Neural Engineering.
Xu Z, Guan CT, So RQ, Ang KK, Toe KK. (2015) Motor Cortical Adaptation Induced by Closed-Loop BCI. Conf Proc 7th International IEEE EMBS Conference on Neural Engineering.

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Responsible Party: National Neuroscience Institute
ClinicalTrials.gov Identifier: NCT03811301     History of Changes
Other Study ID Numbers: BrainConnexion
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Spinal Cord Injuries
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Muscular Dystrophies
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurodegenerative Diseases
Neuromuscular Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Paralysis
Neurologic Manifestations
Signs and Symptoms