ECoG BMI for Motor and Speech Control (BRAVO)
Primary Purpose
ALS, SCI - Spinal Cord Injury, Stroke
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
PMT/Blackrock Combination Device
Sponsored by
About this trial
This is an interventional device feasibility trial for ALS
Eligibility Criteria
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)
Sites / Locations
- University of California San FranciscoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electrocorticography-based brain computer interface
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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
To enable communication via text decoded from neural signals.
NIDCD Primary Objective 2
To enable communication via synthesized speech decoded from neural signals.
Secondary Outcome Measures
NIDCD Secondary Objective 1
To evaluate communication via text decoded from neural signals.
NIDCD Secondary Objective 2
To evaluate communication via synthesized speech decoded from neural signals.
Full Information
NCT ID
NCT03698149
First Posted
August 21, 2018
Last Updated
July 29, 2022
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03698149
Brief Title
ECoG BMI for Motor and Speech Control
Acronym
BRAVO
Official Title
A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
August 15, 2025 (Anticipated)
Study Completion Date
August 15, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ALS, SCI - Spinal Cord Injury, Stroke, Multiple Sclerosis, Muscular Dystrophies
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electrocorticography-based brain computer interface
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PMT/Blackrock Combination Device
Intervention Description
PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
The primary endpoint of this study is to determine the incidence of treatment-emergent adverse events associated with the ECoG-based interface
Time Frame
Up to 6 years post-implant period
Title
NIDCD Primary Objective 1
Description
To enable communication via text decoded from neural signals.
Time Frame
Up to 6 years post-implant period
Title
NIDCD Primary Objective 2
Description
To enable communication via synthesized speech decoded from neural signals.
Time Frame
Up to 6 years post-implant period
Secondary Outcome Measure Information:
Title
NIDCD Secondary Objective 1
Description
To evaluate communication via text decoded from neural signals.
Time Frame
Up to 6 years post-implant period
Title
NIDCD Secondary Objective 2
Description
To evaluate communication via synthesized speech decoded from neural signals.
Time Frame
Up to 6 years post-implant period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adelyn Tu-Chan
Phone
(415) 575-0431
Email
adelyn.tu@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karunesh Ganguly, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adelyn Tu-Chan
Phone
415-575-0431
Email
adelyn.tu@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36347863
Citation
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.
Results Reference
derived
PubMed Identifier
34260835
Citation
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.
Results Reference
derived
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ECoG BMI for Motor and Speech Control
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