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Neural Interface

Brain-Computer Interface for Paralysis

N/A

Waitlist Available

Led By John D Simeral, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, average of 1 month

Awards & highlights

Study Summary

This trial is testing a brain computer interface that would help veterans with tetraplegia or ALS to be more independent.

Who is the study for?

This trial is for Veterans with severe paralysis or inability to speak due to conditions like ALS, spinal cord injury, stroke, and muscular dystrophy. Participants must have little or no use of their arms and legs.Check my eligibility

What is being tested?

The study tests a mobile brain-computer interface (iBCI) designed to help paralyzed individuals operate computers and mobile devices using their thoughts. The device's accuracy and ease of use will be evaluated at home by participants.See study design

What are the potential side effects?

Since this trial involves a non-invasive technology rather than medication, traditional side effects are not applicable. However, there may be discomfort or fatigue from the use of the equipment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, average of 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, average of 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Closed-loop performance in an iBCI cursor task

Trial Design

1Treatment groups

Experimental Treatment

Group I: Evaluation of an enhanced iBCIExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,451 Total Patients Enrolled

John D Simeral, PhDPrincipal InvestigatorProvidence VA Medical Center, Providence, RI

Media Library

Mobile iBCI (Neural Interface) Clinical Trial Eligibility Overview. Trial Name: NCT05470478 — N/A

Spinal Cord Injury Research Study Groups: Evaluation of an enhanced iBCI

Spinal Cord Injury Clinical Trial 2023: Mobile iBCI Highlights & Side Effects. Trial Name: NCT05470478 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this experiment currently available?

"According to clinicaltrials.gov, this experiment is unfortunately no longer recruiting patients. Initially posted on 2nd January 2023 and recently edited in July 2022, the trial has been closed - but 631 other studies remain open for enrollment at present."

Answered by AI

Are there any eligibility requirements to participate in this research?

"This study has 2 vacancies for patients with Weber Syndrome, one aged 18 and the other 80. To qualify, they must fulfil all criteria outlined in BrainGate's Investigational Device Exemption (# NCT00912041) as well as be tetraplegic or anarthric and have minimal functioning of their arms and legs."

Answered by AI

Does this clinical trial extend to minors?

"This medical study is open to individuals aged 18-80. However, if you are under the age of eighteen or above 65 years old, there are 145 and 508 trials respectively that may be better suited for your needs."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

iBCI Optimization for Veterans With Paralysis

2024. "iBCI Optimization for Veterans With Paralysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05470478.

All > Lou Gehrigs Disease > Muscular Dystrophy