NCT03698149 · Karunesh Ganguly
ECoG BMI for Motor and Speech Control
(BRAVO)
What this study is about
Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.
View original scientific description
Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.
Interventions
DEVICE
PMT/Blackrock Combination Device
PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System
Primary outcome measures
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
NIDCD Primary Objective 1
Time frame: Up to 6 years post-implant period
To enable communication via text decoded from neural signals.
NIDCD Primary Objective 2
Time frame: Up to 6 years post-implant period
To enable communication via synthesized speech decoded from neural signals.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- San Francisco, California
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations