Using brain signals to control devices for movement and speech
A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control
This study is testing if people with severe neurological disorders can use brain signals to control devices that help them move and speak better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT03698149 on ClinicalTrials.gov |
What this trial studies
This study tests the feasibility of using electrocorticography (ECoG) signals to enable adults with severe neurological disorders to control complex devices for motor and speech functions. Participants will have electrodes placed on the surface of their brains to record electrical activity, which will be used to train them in controlling a robotic system. The study aims to assess whether these brain signals can facilitate speech production, providing a new avenue for communication and mobility for affected individuals.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 with limited upper limb mobility due to conditions like ALS, spinal cord injury, or stroke, and who have a significant loss of independence.
Not a fit: Patients who are pregnant, unable to understand English, or have severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for patients with severe neurological impairments by restoring their ability to communicate and control devices.
How similar studies have performed: Other studies using ECoG for motor and speech control have shown promise, indicating that this approach is both innovative and grounded in prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 21 2. Limited ability to use upper limbs, based on neurological examination, due to stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis, cervical spinal cord injury, brainstem stroke, muscular dystrophy, myopathy or severe neuropathy. 3. Disability, defined by a 4 or greater score on the Modified Rankin Scale, must be severe enough to cause loss of independence and inability to perform activities of daily living. 4. If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms 5. Must live within a two-hour drive of UCSF Exclusion Criteria: 1. Pregnancy or breastfeeding 2. Inability to understand and/or read English 3. Inability to give consent 4. Dementia, based on history, physical exam, and MMSE 5. Active depression (BDI \> 20) or other psychiatric illness (active general anxiety disorder, schizophrenia, bipolar disorder, obsessive-compulsive disorder (OCD), or personality disorders (e.g. multiple personality disorder, borderline personality disorder, etc.) 6. History of suicide attempt or suicidal ideation 7. History of substance abuse 8. Co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer, or major organ system failure 9. Inability to comply with study follow-up visits 10. Any prior intracranial surgery 11. History of seizures 12. Immunocompromised 13. Has an active infection 14. Has a CSF drainage system or an active CSF leak 15. Requires diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition 16. Has an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump, or presence of any head or neck metallic foreign bodies 17. Allergies or known hypersensitivity to materials in the Blackrock NeuroPort Array (i.e. silicone, titanium) or the PMT Subdural Cortical Electrode (silicone, platinum iridium, nichrome)
Where this trial is running
San Francisco, California
- University of California San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Karunesh Ganguly, MD, PhD — University of California, San Francisco
- Study coordinator: Adelyn Tu-Chan
- Email: adelyn.tu@ucsf.edu
- Phone: (415) 575-0431
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.