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iBCI Optimization for Veterans With Paralysis

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ClinicalTrials.gov Identifier: NCT05470478
Recruitment Status : Not yet recruiting
First Posted : July 22, 2022
Last Update Posted : July 22, 2022
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Amyotrophic Lateral Sclerosis Brain Stem Infarctions Locked-in Syndrome Muscular Dystrophy Device: Mobile neural decoding platform (mobile iBCI) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Enhancement and Optimization of a Mobile iBCI for Veterans With Paralysis
Estimated Study Start Date : January 2, 2023
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Arm Intervention/treatment
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.
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05470478

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Contact: Kate J Barnabe, MHA (401) 273-7100 ext 16272 Kate.Barnabe@va.gov

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United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908
Contact: Kate J Barnabe, MHA    401-273-7100 ext 16272    Kate.Barnabe@va.gov   
Principal Investigator: John D Simeral, PhD         
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: John D Simeral, PhD Providence VA Medical Center, Providence, RI
Additional Information:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT05470478    
Other Study ID Numbers: A3803-R
I01RX003803 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Muscular Dystrophies
Spinal Cord Injuries
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Locked-In Syndrome
Brain Stem Infarctions
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurodegenerative Diseases
Neuromuscular Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Neurologic Manifestations
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders