An interventional study of Mobile neural decoding platform (mobile iBCI) in Spinal Cord Injury, Amyotrophic Lateral Sclerosis and Brain Stem Infarctions, sponsored by VA Office of Research and Development. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other
VA research has been advancing a high-performance brain-computer interface (BCI) to improve independence for Veterans and others living with tetraplegia or the inability to speak resulting from amyotrophic lateral sclerosis, spinal cord injury or stoke. In this project, the investigators enhance deep learning neural network decoders and multi-state gesture decoding for increased accuracy and reliability and deploy them on a battery-powered mobile BCI device for independent use of computers and touch-enabled mobile devices at home. The accuracy and usability of the mobile iBCI will be evaluated with participants already enrolled separately in the investigational clinical trial of the BrainGate neural interface.
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 2 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
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Exclusion Criteria:
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
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.
Time frame: through study completion, average of 1 month
Plan to share: No — Certain clinical data collected in this study are subject to institutional policies and local, state, and Federal laws and regulations, including the HIPAA Privacy Rule, which limit the distribution of such data in order to maintain the rights and privacy of research participants. Figuring out how to truly de-identify datasets, particularly given the range of potential neurological and psychiatric insights that one could, in the future, make from these data, is a considerable ethical challenge. Limited data resulting from this study will be released in association with peer-reviewed manuscripts to provide for independent validation of manuscript results and methods by others in the field. Due to the unique nature of this human trial data, it is expected that consultation with the authors will be required for external parties to perform accurate, appropriate, and meaningful secondary analyses.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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