iBCI Optimization for Veterans With Paralysis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05470478 |
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Recruitment Status :
Not yet recruiting
First Posted : July 22, 2022
Last Update Posted : July 22, 2022
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| 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 |
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 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 |
|---|---|
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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.
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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. |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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).
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
| Contact: Kate J Barnabe, MHA | (401) 273-7100 ext 16272 | Kate.Barnabe@va.gov |
| 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 | |
| Principal Investigator: | John D Simeral, PhD | Providence VA Medical Center, Providence, RI |
| 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. |
| 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 |
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Muscular Dystrophies Spinal Cord Injuries Motor Neuron Disease Amyotrophic Lateral Sclerosis Paralysis Locked-In Syndrome Brain Stem Infarctions Pathologic Processes Infarction Ischemia Necrosis 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 Quadriplegia Brain Infarction Brain Ischemia Cerebrovascular Disorders |