Status:
UNKNOWN
[BrainConnexion] - Neurodevice Phase I Trial
Lead Sponsor:
National Neuroscience Institute
Collaborating Sponsors:
Institute of Microelectronics
Institute of Molecular and Cell Biology
Conditions:
Tetraplegia
Tetraplegia/Tetraparesis
Eligibility:
All Genders
21+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03811301
Start Date
November 21 2017
End Date
August 27 2023
Last Update
May 6 2023
Active Locations (1)
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1
National Neuroscience Institute
Singapore, Singapore, 308433