Cortical Recording and Stimulating Array Brain-Machine Interface (CRS-BMI)
|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: NCT01894802|
Recruitment Status : Recruiting
First Posted : July 10, 2013
Last Update Posted : March 27, 2020
|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 31, 2024|
|Estimated Study Completion Date :||December 2025|
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|
|Contact: Casey Konopisos||412-648-4035||CLK130@pitt.edu|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Debbie E Harrington, BS 412-383-1355 email@example.com|
|Contact: Casey Konopisos 412-648-4035 CLK130@pitt.edu|
|Principal Investigator: Michael L Boninger, MD|
|Principal Investigator:||Michael L Boninger, MD||University of Pittsburgh|