Clinical trial NCT03698149: ECoG BMI for Motor and Speech Control
Official title: A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ALS
SCI - Spinal Cord Injury
Stroke
Multiple Sclerosis
Muscular Dystrophies
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-10-05
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: Inclusion Criteria:

1. Age \&gt; 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 \&gt; 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)

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 6 years post-implant period
measure: NIDCD Primary Objective 1
timeFrame: Up to 6 years post-implant period
measure: NIDCD Primary Objective 2
timeFrame: Up to 6 years post-implant period
Secondary outcomes:
measure: NIDCD Secondary Objective 1
timeFrame: Up to 6 years post-implant period
measure: NIDCD Secondary Objective 2
timeFrame: Up to 6 years post-implant period
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Karunesh Ganguly, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Metzger SL, Liu JR, Moses DA, Dougherty ME, Seaton MP, Littlejohn KT, Chartier J, Anumanchipalli GK, Tu-Chan A, Ganguly K, Chang EF. Generalizable spelling using a speech neuroprosthesis in an individual with severe limb and vocal paralysis. Nat Commun. 2022 Nov 8;13(1):6510. doi: 10.1038/s41467-022-33611-3.
citation: Moses DA, Metzger SL, Liu JR, Anumanchipalli GK, Makin JG, Sun PF, Chartier J, Dougherty ME, Liu PM, Abrams GM, Tu-Chan A, Ganguly K, Chang EF. Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria. N Engl J Med. 2021 Jul 15;385(3):217-227. doi: 10.1056/NEJMoa2027540.