iBCI Optimization for Veterans With Paralysis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inclusion criteria are extensive and are determined by the associated BrainGate IDE(clinicaltrials.gov # NCT00912041)

Informally, participants will be tetraplegic or anarthric with little or no functional use of the arms and legs

Disqualifiers

Exclusion criteria are extensive and are determined by the associated BrainGate IDE(clinicaltrials.gov # NCT00912041).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

2 Participants
are divided into 1 treatment group
Group A: Evaluation of an enhanced iBCIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: