Have you or your loved ones been diagnosed with tetraplegia?

You may be eligible to participate in a tetraplegia clinical trial.

Have you or your loved ones been diagnosed with tetraplegia? You may be eligible to participate in a tetraplegia clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Tetraplegia Clinical Trial in Singapore

NCT03811301 | Interventional

Have you or your loved ones been diagnosed with tetraplegia?

You may be eligible to participate in a tetraplegia clinical trial.

Have you or your loved ones been diagnosed with tetraplegia? You may be eligible to participate in a tetraplegia clinical trial.

Active not recruiting

Male & Female

21 Years +

This study has recruited 5 Participants

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.

Show me more details

Details for the study

Brief Title

[BrainConnexion] - Neurodevice Phase I Trial

Official Title

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

Brief Summary

This study aims to evaluate the safety of a wireless implantable neurodevice microsystem in <br /> tetraplegic patients, as well as the efficacy of the electrodes for long-term recording of <br /> 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.

Treatments and/or Procedures

Brain connexion

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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.

6 months post-implant

Secondary

Time taken to complete each trial per session

This will be measured in seconds (s).

Day 1 to Day 365 post-implant

Secondary

Decoding accuracy per training session.

Decoding accuracy will be measured in percentage (%).

Day 1 to Day 365 post-implant

Secondary

Number of successful trials per session

The number of successful trials per training session will be measured in percentage (%).

Day 1 to Day 365 post-implant

Secondary

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.

Day 1 to Day 365 post-implant

Study 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 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.