Microelectrode Brain-Machine Interface for Individuals With Tetraplegia
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01364480|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2011
Last Update Posted : April 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Tetraplegia Spinal Cord Injury||Device: Implantation of NeuroPort Arrays in the motor cortex||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Microelectrode Brain-Machine Interface for Individuals With Tetraplegia|
|Actual Study Start Date :||May 1, 2011|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2024|
Experimental: Brain-Machine Interface Users
All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group.
Device: Implantation of NeuroPort Arrays in the motor cortex
Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.
- The primary outcome is the safety of the participant. [ Time Frame: One year following array implantation ]This measure will be considered a success if the device is not removed for safety reasons during the post-implant evaluation.
- The secondary outcome is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices. [ Time Frame: One year following array implantation ]The efficacy of the electrodes will be determined through a variety of measures, including characterization of signal quality, degrees of freedom achieved and subject performance.
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): NCT01364480
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Michael L Boninger, MD||University of Pittsburgh|