ALS, Multiple Sclerosis, Muscular Dystrophies, SCI - Spinal Cord Injury, Stroke
Conditions
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.
Interventions
DEVICEPMT/Blackrock Combination Device
PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System
Sponsors
Karunesh Ganguly
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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 1 | Up to 6 years post-implant period | To enable communication via text decoded from neural signals. |
| NIDCD Primary Objective 2 | Up to 6 years post-implant period | To enable communication via synthesized speech decoded from neural signals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NIDCD Secondary Objective 1 | Up to 6 years post-implant period | To evaluate communication via text decoded from neural signals. |
| NIDCD Secondary Objective 2 | Up to 6 years post-implant period | To evaluate communication via synthesized speech decoded from neural signals. |
Countries
United States
Contacts
CONTACTAdelyn Tu-Chan
PRINCIPAL_INVESTIGATORKarunesh Ganguly, MD, PhD
University of California, San Francisco
Outcome results
None listed