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RecruitingNot ApplicableNCT03698149

ECoG BMI for Motor and Speech Control

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

Sponsor

Karunesh Ganguly

Enrollment

3 participants

Start Date

Nov 9, 2018

Study Type

INTERVENTIONAL

Conditions

StrokeMultiple SclerosisALSSCI - Spinal Cord InjuryMuscular Dystrophies

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria5

  • 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 Criteria17

  • 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)

Interventions

DEVICEPMT/Blackrock Combination Device

PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System

Locations(1)

University of California San Francisco

San Francisco, California, United States

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NCT03698149

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