Feasibility of a brain-computer interface for people with tetraplegia
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
NA · Massachusetts General Hospital · NCT00912041
This study is testing a new brain-computer interface that helps people with tetraplegia control a computer and other devices just by thinking, to see if it’s safe and effective.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 5 sites (Sacramento, California and 4 other locations) |
| Trial ID | NCT00912041 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and feasibility of the BrainGate2 intracortical neural interface system, which allows individuals with tetraplegia to control a computer cursor and assistive devices using their thoughts. Participants will have sensors implanted in the motor-related cortex to facilitate this control. The research focuses on developing a medical device that can help restore abilities typically reliant on hand movement or speech for those with severe paralysis. The study will gather preliminary data on device performance and user experience.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with spinal cord injuries, brainstem strokes, or other motor neuron disorders resulting in complete or incomplete tetraplegia.
Not a fit: Patients with significant visual impairments or those on chronic immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this could enable individuals with tetraplegia to regain control over their environment and improve their quality of life.
How similar studies have performed: Other studies have shown promise in using brain-computer interfaces for similar applications, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders * Complete or incomplete tetraplegia (quadriplegia) * Must live within a three-hour drive of the Study site * (There are additional inclusion criteria) Exclusion Criteria: * Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses * Chronic oral or intravenous steroids or immunosuppressive therapy * Other serious disease or disorder that could seriously affect ability to participate in the study * (There are additional exclusion criteria)
Where this trial is running
Sacramento, California and 4 other locations
- University of California, Davis — Sacramento, California, United States (RECRUITING)
- Stanford University School of Medicine — Stanford, California, United States (RECRUITING)
- Emory University School of Medicine — Atlanta, Georgia, United States (RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Providence VA Medical Center — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Principal investigator: Leigh R Hochberg, M.D., Ph.D. — Massachusetts General Hospital
- Study coordinator: Leigh R Hochberg, M.D., Ph.D.
- Email: clinicaltrials@braingate.org
- Phone: 617-724-9247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked in Syndrome, Muscular Dystrophy, Brain computer interface, Assistive device