Using a neural interface to help people with tetraplegia control devices with their thoughts
Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis
This study is testing a new brain interface that helps people with tetraplegia, especially those with ALS, control devices like computers just by thinking about it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Stanford, California and 1 other locations) |
| Trial ID | NCT05724173 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and feasibility of the BrainGate2 Neural Interface System, which allows individuals with tetraplegia to control a computer cursor and other assistive devices using their thoughts. Participants will be individuals diagnosed with amyotrophic lateral sclerosis (ALS) who experience severe speech impairment. The study will assess the device's ability to restore certain abilities that are typically reliant on hand movement or speech. The research is conducted at prominent medical institutions to ensure rigorous evaluation and oversight.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with a diagnosis of ALS and severe speech impairment.
Not a fit: Patients with visual impairments that hinder their ability to use a computer monitor may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly enhance the quality of life for patients with severe mobility and communication impairments.
How similar studies have performed: Previous studies using similar neural interface technologies have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 18 and 80 years of age. * Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases. * Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months. * Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment. 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
Stanford, California and 1 other locations
- Stanford University School of Medicine — Stanford, California, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jaimie Henderson, MD — Stanford University
- Study coordinator: Leigh R Hochberg, MD, Ph.D
- Email: lhochberg@mgh.harvard.edu
- 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.