TrialBridgeNCT07933549
REstoration of Communication and LAnguage With Intracortical Microelectrodes
Not Yet Recruiting · Not Applicable · The University of Texas Health Science Center, Houston · registry updated 2026-11-12
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The purpose of this study is to investigate the safety and feasibility of using distributed intracortical recordings from the language network to decode intended language output in individuals with severe communication impairment due to severe communication impairment resulting from amyotrophic lateral sclerosis (ALS), locked-in syndrome, and brain injury including from stroke.
Inclusion
- 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
Exclusion
- 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.
- 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.
- 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.