Trials / Unknown
UnknownNCT03811301
[BrainConnexion] - Neurodevice Phase I Trial
Neurodevice Phase I: Wireless Implantable Neurodevice Microsystem for Neuroprosthesis and Neuroscience
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- National Neuroscience Institute · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Tetraplegia
- Tetraplegia/Tetraparesis
- Spinal Cord Injuries
- Amyotrophic Lateral Sclerosis
- Motor Neuron Disease
- Locked-in Syndrome
- Muscular Dystrophies
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-11-21
- Primary completion
- 2023-01-27
- Completion
- 2023-08-27
- First posted
- 2019-01-22
- Last updated
- 2023-05-06
Locations
1 site across 1 country: Singapore
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03811301. Inclusion in this directory is not an endorsement.