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ECoG BMI for Motor and Speech Control (BRAVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03698149
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Karunesh Ganguly, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
ALS SCI - Spinal Cord Injury Stroke Multiple Sclerosis Muscular Dystrophies Device: PMT/Blackrock Combination Device Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : August 15, 2024
Estimated Study Completion Date : August 15, 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electrocorticography-based brain computer interface Device: PMT/Blackrock Combination Device
PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698149


Contacts
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Contact: Adelyn Tu-Chan (415) 575-0431 adelyn.tu@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Adelyn Tu-Chan    415-575-0431    adelyn.tu@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco

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Responsible Party: Karunesh Ganguly, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03698149     History of Changes
Other Study ID Numbers: 17-23028
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Muscular Dystrophies
Multiple Sclerosis
Spinal Cord Injuries
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn