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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Closed-loop performance in an iBCI cursor task

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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