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NCT Number: NCT03698149

ECoG BMI for Motor and Speech Control

Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

PMT/Blackrock Combination Device

Device

PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System

Primary outcomes

  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

  2. NIDCD Primary Objective 1

    Time frame: Up to 6 years post-implant period

    To enable communication via text decoded from neural signals.

  3. NIDCD Primary Objective 2

    Time frame: Up to 6 years post-implant period

    To enable communication via synthesized speech decoded from neural signals.

Secondary outcomes

  1. NIDCD Secondary Objective 1

    Time frame: Up to 6 years post-implant period

    To evaluate communication via text decoded from neural signals.

  2. NIDCD Secondary Objective 2

    Time frame: Up to 6 years post-implant period

    To evaluate communication via synthesized speech decoded from neural signals.

Study contacts

Contact information is provided by the study sponsor or research team.

Adelyn Tu-Chan

CONTACT

[email protected]

(415) 575-0431

Sponsors and collaborators

Lead sponsor

Karunesh Ganguly

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

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

Acronym: BRAVO

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
Oct 5, 2018
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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