iBCI Optimization for Veterans With Paralysis

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05470478
Study type	Interventional
Source	VA Office of Research and Development
Contact	Kate J Barnabe, MHA
Phone	(401) 273-7100
Email	Kate.Barnabe@va.gov
Status	Not yet recruiting
Phase	N/A
Start date	September 1, 2024
Completion date	June 30, 2026

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04428775` - A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease	Phase 2
Recruiting	`NCT04998305` - TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps	Phase 1/Phase 2
Recruiting	`NCT05951556` - Telehealth Implementation of Brain-Computer Interface	N/A
Terminated	`NCT04579666` - MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)	Phase 2
Recruiting	`NCT04082832` - CuATSM Compared With Placebo for Treatment of ALS/MND	Phase 2/Phase 3
Completed	`NCT01925196` - Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
Completed	`NCT02496767` - Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year	Phase 3
Recruiting	`NCT04816227` - Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
Active, not recruiting	`NCT04494256` - A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation	Phase 1/Phase 2
Completed	`NCT03706391` - Study of ALS Reversals 4: LifeTime Exposures
Recruiting	`NCT04882904` - Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.	N/A
Completed	`NCT04557410` - Open Label Study: Treatment of ALS Fatigue With PolyMVA	Phase 1
Active, not recruiting	`NCT04948645` - A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis	Phase 1
Not yet recruiting	`NCT04089696` - Validation of the "ExSpiron©" in Patients With ALS	N/A
Not yet recruiting	`NCT05860244` - Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients	Phase 2
Not yet recruiting	`NCT04220190` - RAPA-501 Therapy for ALS	Phase 2/Phase 3
Not yet recruiting	`NCT06450691` - Modeling Amyotrophic Lateral Sclerosis With Fibroblasts	N/A
Recruiting	`NCT02917681` - Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis	Phase 1/Phase 2
Active, not recruiting	`NCT03067857` - Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease	Phase 1/Phase 2
Recruiting	`NCT02874209` - Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis	N/A