Neurodevice Phase II: Wireless Implantable Neurodevice Microsystem for Neuroprosthesis and Neuroscience

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:

NCT03811301

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:

3

Estimated Study Start Date:

11 / 21 / 2017

Estimated Study Completion Date:

12 / 31 / 2021

Posting Last Modified Date:

03 / 04 / 2021

Date Study Added to neals.org:

01 / 22 / 2019

Minimum Age:

21 Years

Maximum Age:

70 Years

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.

National Neuroscience Institute

Singapore 308433
Singapore