REstoration of Communication and LAnguage With Intracortical Microelectrodes

Ki vehet részt

• Clinical diagnosis of ALS, locked-in syndrome, or stroke; ALS - ALS patients who in the opinion of the treating neurologist have at least 3 years of survival; Locked-in Syndrome as a result of brain-stem stroke or traumatic brain-stem injury - patients who in the opinion of the treating neurologist have at least 3 years of survival; Stroke (either ischemic or hemorrhagic) - for patients with prior stroke, the original cause of the stroke (e.g., arteriovenous malformation, carotid stenosis, atrial fibrillation, heart disease, hypertension) must have been addressed and the patient must not have had a recurrent stroke at least within the prior 12 months
• ALS diagnosis, stroke, or Locked-in syndrome (LIS) etiology onset occurred at least one year prior to enrollment
• Minimal communication ability as assessed by a speech-language pathologist; unable to produce more than 10 total unique intelligible words when reading the Rainbow Passage and Grandfather Passage, and; unable to write or type more than 10 unique words from a dictated list of 20 words
• Limited upper limb strength based on the Medical Research Council Scale for Muscle Strength; ≤3/5 strength throughout both arms for those with non-progressive conditions (stroke or traumatic brain-stem injury); ≤4/5 strength throughout both arms for those with ALS; For patients with 4/5 strength, they must have a documented decline in speech or upper extremity function in the preceding 12 months
• Has a means of communication sufficient to enable understanding of research protocol and provide consent (e.g. eye blinks or eye movements, use of assistive technology). Thus patients are severely impaired with regards to naturalistic communication, but able to make decisions regarding their own care
• Ability to understand and comply with study session instructions
• Must live within a 90-minute drive of study site and willing to travel to study site up to three days per week for duration of the study
• Has a stable psychosocial support system with caregiver capable of providing care during post-operative periods and monitoring participant throughout the study
• Stable ventilator status - ventilator requirements have not changed over prior 6 months and ventilator status does not impose additional substantial risks to subject participation, including travel to the investigation site

Ki nem vehet részt

• Neurological disorders including current diagnosis of epilepsy, abnormal pre-surgical neuroimaging precluding safe implant placement (per neurosurgical team), prior ipsilateral craniotomy, or hydrocephalus with or without ventricular shunt
• Surgical contraindications including medical contraindications to general anesthesia, craniotomy, or surgery; significant pulmonary, metabolic, or renal impairments making surgical procedure unsafe
• Other exclusions including pregnancy (confirmed by blood test), nursing, inadequate contraception, correction vision worse than 20/100, limited English proficiency, or concurrent participation in device/drug trials
• Psychiatric conditions including current diagnosis of major psychiatric illness, significant cognitive impairment (based on a neuropsychological assessment by a clinical psychologist), suicidal ideation with intent/plan. [Columbia-Suicide Severity Rating Scale (C-SSRS) Categories 4-5)] or suicidal behavior within 12 months, or substance abuse/narcotic/alcohol dependence within 12 months
• Implanted electronic devices including pacemakers, cardiac defibrillators, spinal cord stimulators, vagal nerve stimulators, deep brain stimulators, or cochlear implants
• Cardiovascular disorders including acute myocardial infarction (MI) or cardiac arrest within 6 months, significant cardiovascular impairment contraindicating surgery
• Hematological disorders requiring chronic anticoagulation and medical contraindication to discontinuing anticoagulant medications perioperatively
• Dermatological conditions causing excessive skin sloughing, poor wound healing, existing scalp lesions, or skin breakdown
• Infectious/immunological conditions including active infections, unexplained fever, HIV infection, ongoing chronic infections, medical conditions predisposing to high infection risk, chronic steroid or immunosuppressive therapy, or active cancer within 1 year requiring chemotherapy
• Medical contraindications including conditions contraindicating chronically implanted devices (osteomyelitis, diabetes, hepatic failure, autoimmune disease/disorders with associated altered immune responses) or other chronic unstable medical conditions interfering with participation