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ECoG BMI for Motor and Speech Control (BRAVO)

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ClinicalTrials.gov Identifier: NCT03698149
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Karunesh Ganguly, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 21, 2018
First Posted Date  ICMJE October 5, 2018
Last Update Posted Date February 24, 2020
Actual Study Start Date  ICMJE August 15, 2018
Estimated Primary Completion Date August 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ECoG BMI for Motor and Speech Control
Official Title  ICMJE A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • ALS
  • SCI - Spinal Cord Injury
  • Stroke
  • Multiple Sclerosis
  • Muscular Dystrophies
Intervention  ICMJE Device: PMT/Blackrock Combination Device
PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System
Study Arms  ICMJE Experimental: Electrocorticography-based brain computer interface
Intervention: Device: PMT/Blackrock Combination Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2018)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2030
Estimated Primary Completion Date August 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adelyn Tu-Chan (415) 575-0431 adelyn.tu@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03698149
Other Study ID Numbers  ICMJE 17-23028
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karunesh Ganguly, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karunesh Ganguly, MD, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP