- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03698149
ECoG BMI for Motor and Speech Control (BRAVO)
March 17, 2024 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
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
- Name: Adelyn Tu-Chan
- Phone Number: (415) 575-0431
- Email: adelyn.tu@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- Recruiting
- University of California San Francisco
-
Contact:
- Adelyn Tu-Chan
- Phone Number: 415-575-0431
- Email: adelyn.tu@ucsf.edu
-
-
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:
- 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)
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
|
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
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
- Metzger SL, Liu JR, Moses DA, Dougherty ME, Seaton MP, Littlejohn KT, Chartier J, Anumanchipalli GK, Tu-Chan A, Ganguly K, Chang EF. Generalizable spelling using a speech neuroprosthesis in an individual with severe limb and vocal paralysis. Nat Commun. 2022 Nov 8;13(1):6510. doi: 10.1038/s41467-022-33611-3.
- Moses DA, Metzger SL, Liu JR, Anumanchipalli GK, Makin JG, Sun PF, Chartier J, Dougherty ME, Liu PM, Abrams GM, Tu-Chan A, Ganguly K, Chang EF. Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria. N Engl J Med. 2021 Jul 15;385(3):217-227. doi: 10.1056/NEJMoa2027540.
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, 2025
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)
March 19, 2024
Last Update Submitted That Met QC Criteria
March 17, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Wounds and Injuries
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- Muscular Disorders, Atrophic
- Multiple Sclerosis
- Muscular Dystrophies
- Spinal Cord Injuries
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
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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