iBCI Optimization for Veterans With Paralysis

NCT05470478 | Not Yet Recruiting FDA Device

• 2 other identifiers: A3803-RI01RX003803
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

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.

  through study completion, average of 1 month

Study Arms (1)

Evaluation of an enhanced iBCI

EXPERIMENTAL

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)

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.

Evaluation of an enhanced iBCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

Related Links

• 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.

MeSH Terms

Conditions

Spinal Cord Injuries; Amyotrophic Lateral Sclerosis; Brain Stem Infarctions; Locked-In Syndrome; Muscular Dystrophies

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Quadriplegia; Paralysis; Neurologic Manifestations; Signs and Symptoms; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• John D Simeral, PhD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate J Barnabe, MHA

CONTACT

(401) 273-7100; Kate.Barnabe@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 22, 2022
• Study Start (Estimated): June 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)