[BrainConnexion] - Neurodevice Phase II Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03811301|
Recruitment Status : Recruiting
First Posted : January 22, 2019
Last Update Posted : January 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tetraplegia Tetraplegia/Tetraparesis Spinal Cord Injuries Amyotrophic Lateral Sclerosis Motor Neuron Disease Locked-in Syndrome Muscular Dystrophies||Device: BrainConnexion||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neurodevice Phase II: Wireless Implantable Neurodevice Microsystem for Neuroprosthesis and Neuroscience|
|Actual Study Start Date :||November 21, 2017|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Wireless Implantable Neurodevice Microsystem
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.
- The number of serious adverse events (SAEs) and adverse events (AEs) reported per patient 12 months post-implantation. [ Time Frame: 12 months post-implant ]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.
- The signal quality of the electrodes for long-term recording of neural signals. [ Time Frame: Day 1 to Day 365 post-implant ]Signal quality will be measured by the number of channels with identifiable single units tracked across each day for 12 months.
- Decoding accuracy per training session. [ Time Frame: Day 1 to Day 365 post-implant ]Decoding accuracy will be measured in percentage (%).
- Number of successful trials per session [ Time Frame: Day 1 to Day 365 post-implant ]The number of successful trials per training session will be measured in percentage (%).
- Time taken to complete each trial per session [ Time Frame: Day 1 to Day 365 post-implant ]This will be measured in seconds (s).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811301
|Contact: Wai Hoe Ng, MD, FRACS||(65) 6357 firstname.lastname@example.org|
|National Neuroscience Institute||Recruiting|
|Singapore, Singapore, 308433|
|Contact: Wai Hoe Ng, MD, FRACS (65) 6357 7506 email@example.com|
|Principal Investigator: Wai Hoe Ng, MD, FRACS|
|Sub-Investigator: Rosa So|
|Sub-Investigator: Yuan Gao|
|Sub-Investigator: Kai Keng Ang|
|Sub-Investigator: Jai Rao|
|Sub-Investigator: Karen Chua|
|Sub-Investigator: Brian Premchand|
|Sub-Investigator: Juanhong Yu|
|Sub-Investigator: Huijuan Yang|
|Sub-Investigator: Tao Yang|
|Sub-Investigator: Kyaw Kyar Toe|
|Sub-Investigator: Kok Soon Phua|
|Sub-Investigator: Thevapriya Selvaratnam|
|Sub-Investigator: Valerie E Toh|