Spinal Cord InjuryNCT05470478
iBCI Optimization for Veterans With Paralysis
A study testing Mobile neural decoding platform (mobile iBCI) in people with Spinal Cord Injury and Amyotrophic Lateral Sclerosis, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions
- What is being tested?
- Mobile neural decoding platform (mobile iBCI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Exclusion criteria are extensive and are determined by the associated BrainGate IDE(clinicaltrials.gov # NCT00912041).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
Kate J Barnabe, MHA, 401-273-7100 ext. 16272, Kate.Barnabe@va.gov
John D Simeral, PhD
About this study
Official title: Enhancement and Optimization of a Mobile iBCI for Veterans With Paralysis
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.
Read the 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.
- Conditions
- Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked-in Syndrome, Muscular Dystrophy
- Being tested
- Mobile neural decoding platform (mobile iBCI)
- Medical subject headings
- Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked-In Syndrome, Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mobile neural decoding platform (mobile iBCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start2 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John D Simeral, PhD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470478
- Sponsor's protocol ID
- A3803-R
- Other IDs
- I01RX003803
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement and Optimization of a Mobile iBCI for Veterans With Paralysis
- ClinicalTrials.gov ID
- NCT05470478
- Acronym / sponsor ID
- A3803-R
- Conditions
- Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked-in Syndrome, Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Evaluation of an enhanced iBCI | Experimental | Device: Mobile neural decoding platform (mobile 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Exclusion criteria are extensive and are determined by the associated BrainGate IDE(clinicaltrials.gov # NCT00912041).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Evaluation of an enhanced iBCI |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for Spinal Cord Injury
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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
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A Neuroprosthesis for Seated Posture and Balance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John D Simeral, PhD principal investigator
Providence VA Medical Center, Providence, RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile neural decoding platform (mobile iBCI) in people with Spinal Cord Injury and Amyotrophic Lateral Sclerosis, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate J Barnabe, MHA ((401) 273-7100 ext. 16272, Kate.Barnabe@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closed-loop performance in an iBCI cursor task (time frame: through study completion, average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.