iBCI Optimization for Veterans With Paralysis

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
VA Office of Research and Development
Study ID
NCT05470478
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Mobile neural decoding platform (mobile iBCI) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
2 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Closed-loop performance in an iBCI cursor task [ Time Frame: through study completion, average of 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Providence VA Medical Center, Providence, RIProvidenceRhode Island02908-4734
Kate J Barnabe, MHA
[email protected]
401-273-7100
John D Simeral, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Providence VA Medical Center, Providence, RI· Providence, RI

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