Cortical Recording and Stimulating Array Brain-Machine Interface (CRS-BMI)
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|ClinicalTrials.gov Identifier: NCT01894802|
Recruitment Status : Recruiting
First Posted : July 10, 2013
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tetraplegia Spinal Cord Injury Brainstem Stroke||Device: Implantation of CRS Arrays||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Tetraplegia|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Brain-Machine Interface Users
All participants enrolled in the study who meet eligibility criteria will be individuals implanted with microelectrodes in their brain to record neural activity. There is no control group.
Device: Implantation of CRS Arrays
Two Blackrock Microsystems CRS Arrays will be implanted in the motor cortex and sensory 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 12-month 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 CRS Arrays 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): NCT01894802
|Contact: Debbie E Harrington, BSfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Debbie E Harrington, BS 412-383-1355 email@example.com|
|Principal Investigator: Michael L Boninger, MD|
|Principal Investigator:||Michael L Boninger, MD||University of Pittsburgh|