ECoG BMI for Motor and Speech Control (BRAVO)
|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: NCT03698149|
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : August 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|ALS SCI - Spinal Cord Injury Stroke Multiple Sclerosis Muscular Dystrophies||Device: PMT/Blackrock Combination Device||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control|
|Actual Study Start Date :||November 9, 2018|
|Estimated Primary Completion Date :||August 15, 2025|
|Estimated Study Completion Date :||August 15, 2030|
|Experimental: Electrocorticography-based brain computer interface||
Device: PMT/Blackrock Combination Device
PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 6 years post-implant period ]The primary endpoint of this study is to determine the incidence of treatment-emergent adverse events associated with the ECoG-based interface
- NIDCD Primary Objective 1 [ Time Frame: Up to 6 years post-implant period ]To enable communication via text decoded from neural signals.
- NIDCD Primary Objective 2 [ Time Frame: Up to 6 years post-implant period ]To enable communication via synthesized speech decoded from neural signals.
- NIDCD Secondary Objective 1 [ Time Frame: Up to 6 years post-implant period ]To evaluate communication via text decoded from neural signals.
- NIDCD Secondary Objective 2 [ Time Frame: Up to 6 years post-implant period ]To evaluate communication via synthesized speech decoded from neural signals.
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): NCT03698149
|Contact: Adelyn Tu-Chan||(415) email@example.com|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Adelyn Tu-Chan 415-575-0431 firstname.lastname@example.org|
|Principal Investigator:||Karunesh Ganguly, MD, PhD||University of California, San Francisco|