Using a brain-computer interface to help people with speech difficulties communicate
Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface
NA · Massachusetts General Hospital · NCT06094205
This study is testing a brain-computer interface to help people who can't speak due to conditions like ALS communicate by turning their thoughts into speech.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06094205 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance communication for individuals who have lost the ability to speak due to neurological conditions such as ALS or spinal cord injuries. It utilizes an implanted brain-computer interface (iBCI) that captures brain activity when participants attempt to speak, translating their intentions into computer-generated speech. By analyzing how brain cells work together to produce speech, the study seeks to improve the technology and understanding of speech production in affected individuals.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with complete or incomplete tetraplegia or other motor neuron disorders.
Not a fit: Patients with severe visual impairments or those on chronic immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve communication abilities for patients with severe speech impairments.
How similar studies have performed: Other studies involving brain-computer interfaces have shown promise in restoring communication abilities, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 18 and 80 years of age * 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 and geographically stable for at least 15 months after enrollment. (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
- University of California, Davis — Sacramento, California, United States (RECRUITING)
Study contacts
- Principal investigator: Sergey Stavisky, Ph.D. — University of California, Davis
- Study coordinator: Leigh R. Hochberg, M.D., 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.
Conditions: Anarthria, Dysarthria, Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked-in Syndrome, Muscular Dystrophies