ECoG BMI for Motor and Speech Control (BRAVO)

April 30, 2026 updated by: Karunesh Ganguly

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 6 years post-implant period
NIDCD Primary Objective 1
Time Frame: Up to 6 years post-implant period
To enable communication via text decoded from neural signals.
Up to 6 years post-implant period
NIDCD Primary Objective 2
Time Frame: Up to 6 years post-implant period
To enable communication via synthesized speech decoded from neural signals.
Up to 6 years post-implant period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIDCD Secondary Objective 1
Time Frame: Up to 6 years post-implant period
To evaluate communication via text decoded from neural signals.
Up to 6 years post-implant period
NIDCD Secondary Objective 2
Time Frame: Up to 6 years post-implant period
To evaluate communication via synthesized speech decoded from neural signals.
Up to 6 years post-implant period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karunesh Ganguly

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Karunesh Ganguly, MD, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2018

Primary Completion (Estimated)

August 15, 2030

Study Completion (Estimated)

August 15, 2030

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

October 3, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-23028
  • U01DC018671 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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