iBCI Optimization for Veterans With Paralysis
|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: NCT05470478|
Recruitment Status : Not yet recruiting
First Posted : July 22, 2022
Last Update Posted : July 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury Amyotrophic Lateral Sclerosis Brain Stem Infarctions Locked-in Syndrome Muscular Dystrophy||Device: Mobile neural decoding platform (mobile iBCI)||Not Applicable|
After VA IRB approval, this VA RR&D study will engage participants in the BrainGate clinical trial (IDE, sponsor-investigator LR Hochberg). This study does not create a new clinical trial or modify the existing clinical trial as already listed on clinicaltrials.gov
This project builds on a custom, mobile neural signal processing device with exceptional processing and low power characteristics, which has been developed through previous VA RR&D funded research. This project takes advantage of the exceptional processing system, previously developed and validated, to create and quantify advanced neural decoding algorithms that show promise (in preclinical studies) for improving the accuracy and reliability of neural decoding - but that are likely too computationally demanding to be viable on existing real-time BCI systems. Decoding methods will include magnitude kinematic decoding with recursive neural networks and high-dimensional discrete gesture decoding. Computational methods to be evaluated include latent space methods and stable manifolds to improve day-to-day reliability of high performance and high-dimensional orthogonalization approaches to improve the independence of kinematic and gesture decoding.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Each participant enrolled in this early feasibility study is essentially an independent data point. The primary outcome of the IDE to which this VA study is attached is safety; feasibility is a secondary outcome. The outcome of this specific VA study, which engages participants in the BrainGate IDE, is usability of the mobile iBCI decoding system as measured through quantitative performance measures.|
|Masking:||None (Open Label)|
|Official Title:||Enhancement and Optimization of a Mobile iBCI for Veterans With Paralysis|
|Estimated Study Start Date :||January 2, 2023|
|Estimated Primary Completion Date :||June 30, 2026|
|Estimated Study Completion Date :||June 30, 2026|
Experimental: Evaluation of an enhanced iBCI
Performance of new decoding algorithms and methods will be developed and embedded in a small, mobile neural processor. The utility of these will be assessed separately with participants in the BrainGate pilot clinical trial, IDE.
Device: Mobile neural decoding platform (mobile iBCI)
An embedded neural signal processor device will be evaluated for its ability to provide accurate and reliable closed-loop control in a home-based brain-computer interface.
- Closed-loop performance in an iBCI cursor task [ Time Frame: through study completion, average of 1 month ]Rate of successful closed-loop acquisition of on-screen targets using imagined gestures to move a computer cursor or to select icons on a computer screen.
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): NCT05470478
|Contact: Kate J Barnabe, MHA||(401) 273-7100 ext 16272||Kate.Barnabe@va.gov|
|United States, Rhode Island|
|Providence VA Medical Center, Providence, RI|
|Providence, Rhode Island, United States, 02908|
|Contact: Kate J Barnabe, MHA 401-273-7100 ext 16272 Kate.Barnabe@va.gov|
|Principal Investigator: John D Simeral, PhD|
|Principal Investigator:||John D Simeral, PhD||Providence VA Medical Center, Providence, RI|