iBCI Optimization for Veterans With Paralysis

NCT ID: NCT05470478

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-16

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Injury Amyotrophic Lateral Sclerosis Brain Stem Infarctions Locked-in Syndrome Muscular Dystrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mobile neural decoding platform (mobile iBCI)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John D Simeral, PhD

Role: PRINCIPAL_INVESTIGATOR

Providence VA Medical Center, Providence, RI

Locations

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Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Site Status

Countries

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United States

Central Contacts

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Kate J Barnabe, MHA

Role: CONTACT

(401) 273-7100 ext. 16272

Facility Contacts

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Kate J Barnabe, MHA

Role: primary

401-273-7100 ext. 16272

Related Links

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https://www.clinicaltrials.gov/ct2/show/record/NCT00912041?view=record

This VA study does not create or modify a clinical trial. This Links to the associated clinical trial (IDE) which this particular VA study leverages.

Other Identifiers

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I01RX003803

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A3803-R

Identifier Type: -

Identifier Source: org_study_id

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