Summary

for people ages 21 years and up (full criteria)
at San Francisco, California
study started
estimated completion:
Karunesh Ganguly

Description

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.

Official Title

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

Details

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 wearable hand robotic exoskeleton and determine if ECoG brain signals can be used to produce speech.

Keywords

ALS SCI - Spinal Cord Injury Stroke Multiple Sclerosis Muscular Dystrophies Spinal Cord Injuries PMT/Blackrock Combination Device Electrocorticography-based brain computer interface

Eligibility

You can join if…

Open to people ages 21 years and up

  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

You CAN'T join if...

  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)

Location

  • University of California San Francisco accepting new patients
    San Francisco California 94158 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03698149
Phase
Phase 1
Lead Scientist
Karunesh Ganguly
Study Type
Interventional
Last Updated