ECoG BMI for Motor and Speech Control

Study Overview
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Brief Summary
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Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.

Detailed Description
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ECoG is a type of electrophysiological monitoring that uses electrodes placed directly on the exposed surface of the brain to record electrical activity. With this ECoG-based neural interface, study patients will undergo training and assessment of their ability to control a complex robotic system and to determine if ECoG brain signals can be used to produce speech.

Official Title
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A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control

Conditions
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ALS, SCI - Spinal Cord Injury, Stroke, Multiple Sclerosis, Muscular Dystrophies

Intervention / Treatment
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* Device: PMT/Blackrock Combination Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 21 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. 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. If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms Must live within a two-hour drive of UCSF Exclusion Criteria: Pregnancy or breastfeeding Inability to understand and/or read English Inability to give consent Dementia, based on history, physical exam, and MMSE 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.) History of suicide attempt or suicidal ideation History of substance abuse Co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer, or major organ system failure Inability to comply with study follow-up visits Any prior intracranial surgery History of seizures Immunocompromised Has an active infection Has a CSF drainage system or an active CSF leak Requires diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition 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 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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrocorticography-based brain computer interface<br> | Device: PMT/Blackrock Combination Device<br>* PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The primary endpoint of this study is to determine the incidence of treatment-emergent adverse events associated with the ECoG-based interface | Up to 6 years post-implant period | 
| NIDCD Primary Objective 1 | To enable communication via text decoded from neural signals. | Up to 6 years post-implant period | 
| NIDCD Primary Objective 2 | To enable communication via synthesized speech decoded from neural signals. | Up to 6 years post-implant period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIDCD Secondary Objective 1 | To evaluate communication via text decoded from neural signals. | Up to 6 years post-implant period | 
| NIDCD Secondary Objective 2 | To evaluate communication via synthesized speech decoded from neural signals. | Up to 6 years post-implant period |