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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

About this trial

This is an interventional device feasibility trial for ALS

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

adelyn.tu@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD

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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