ECoG BMI for Motor and Speech Control

Stroke Clinical Trial

— BRAVO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03698149
• Other study ID #: 17-23028
• Secondary ID: U01DC018671
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: August 15, 2030

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Adelyn Tu-Chan
• Phone: (415) 575-0431
• Email: adelyn.tu[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: August 15, 2030
• Est. primary completion date: August 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• ALS
• Multiple Sclerosis
• Muscular Dystrophies
• SCI - Spinal Cord Injury
• Spinal Cord Injuries
• Stroke

Intervention

Device:
• PMT/Blackrock Combination Device
PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Karunesh Ganguly	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 6 years post-implant period
Primary	NIDCD Primary Objective 1	To enable communication via text decoded from neural signals.	Up to 6 years post-implant period
Primary	NIDCD Primary Objective 2	To enable communication via synthesized speech decoded from neural signals.	Up to 6 years post-implant period
Secondary	NIDCD Secondary Objective 1	To evaluate communication via text decoded from neural signals.	Up to 6 years post-implant period
Secondary	NIDCD Secondary Objective 2	To evaluate communication via synthesized speech decoded from neural signals.	Up to 6 years post-implant period