ECoG BMI for Motor and Speech Control

Launched by KARUNESH GANGULY · Oct 3, 2018

Keywords

ClinConnect Summary

This clinical trial, titled "ECoG BMI for Motor and Speech Control," is exploring a new way to help people with severe neurological conditions, such as ALS (amyotrophic lateral sclerosis), spinal cord injuries, strokes, multiple sclerosis, and muscular dystrophies. The goal is to see if brain signals, collected using a method called electrocorticography (ECoG), can be used to control devices that assist with movement and speech. The trial is currently recruiting participants who are at least 21 years old and have significant difficulties using their arms due to their conditions, which must have started at least one year ago.

To participate, you should live within a two-hour drive of UCSF and have a substantial loss of independence, as measured by a specific scale. Unfortunately, people who are pregnant, have certain mental health issues, or have specific medical histories, such as previous brain surgery or active infections, are not eligible. Participants can expect to be part of a study that could lead to innovative ways to improve communication and mobility for individuals with serious disabilities. If you or a loved one are interested in learning more, it may be a great opportunity to contribute to important research.

Gender

ALL

Eligibility 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)