BRAVO: ECoG BMI for Motor and Speech Control

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03698149
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 141.2
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
ALS; SCI - Spinal Cord Injury; Stroke; Multiple Sclerosis; Muscular Dystrophies	Device: PMT/Blackrock Combination Device	Early Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control
• Actual Study Start Date: Nov 9, 2018
• Anticipated Primary Completion Date: Aug 15, 2025
• Anticipated Study Completion Date: Aug 15, 2030

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [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

2. NIDCD Primary Objective 1 [Up to 6 years post-implant period]

   To enable communication via text decoded from neural signals.

3. NIDCD Primary Objective 2 [Up to 6 years post-implant period]

   To enable communication via synthesized speech decoded from neural signals.

Secondary Outcome Measures

1. NIDCD Secondary Objective 1 [Up to 6 years post-implant period]

   To evaluate communication via text decoded from neural signals.

2. NIDCD Secondary Objective 2 [Up to 6 years post-implant period]

   To evaluate communication via synthesized speech decoded from neural signals.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco	San Francisco	California	United States	94158

Sponsors and Collaborators

• University of California, San Francisco

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karunesh Ganguly, Associate Professor, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03698149
• Other Study ID Numbers: 17-23028; U01DC018671
• First Posted: Oct 5, 2018
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Muscular Dystrophies; Multiple Sclerosis; Spinal Cord Injuries

Study Results

No Results Posted as of Aug 2, 2022