A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- NIDCD Primary Objective 1
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Electrocorticography-based brain computer interface
Intervention: PMT/Blackrock Combination Device (Device)
Outcomes
Primary Outcomes
NIDCD Primary Objective 1
Time Frame: Up to 6 years post-implant period
To enable communication via text decoded from neural signals.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 6 years post-implant period
The primary endpoint of this study is to determine the incidence of treatment-emergent adverse events associated with the ECoG-based interface
NIDCD Primary Objective 2
Time Frame: Up to 6 years post-implant period
To enable communication via synthesized speech decoded from neural signals.
Secondary Outcomes
- NIDCD Secondary Objective 1(Up to 6 years post-implant period)
- NIDCD Secondary Objective 2(Up to 6 years post-implant period)
Investigators
Karunesh Ganguly
Associate Professor
University of California, San Francisco