Study Purpose:
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.Study Status:
Not recruiting
Disease:
Tetraplegia , Tetraplegia/Tetraparesis , Spinal Cord Injuries , Amyotrophic Lateral Sclerosis , Motor Neuron Disease , Locked-in Syndrome , Muscular Dystrophies
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
BrainConnexion
Placebo:
No
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Full Study Summary:
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 Sponsor:
National Neuroscience Institute
Estimated Enrollment:
5
Estimated Study Start Date:
11 / 21 / 2017
Estimated Study Completion Date:
08 / 27 / 2023
Posting Last Modified Date:
05 / 06 / 2023
Date Study Added to neals.org:
01 / 22 / 2019
Minimum Age:
21 Years
Maximum Age:
N/A
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.
National Neuroscience Institute
Singapore 308433
Singapore