ECoG BMI for Motor and Speech Control

Not Applicable

Recruiting

• Conditions: Stroke; ALS; SCI - Spinal Cord Injury; Multiple Sclerosis; Muscular Dystrophies
• Interventions: Device: PMT/Blackrock Combination Device

• Registration Number: NCT03698149
• Lead Sponsor: Karunesh Ganguly

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.

Study Timeline

• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-05
• Study Start: 2018-11-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-08-15
• Study Completion: 2030-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrocorticography-based brain computer interface	PMT/Blackrock Combination Device	-

Primary Outcome Measures

Name	Time	Method
NIDCD Primary Objective 1	Up to 6 years post-implant period	To enable communication via text decoded from neural signals.
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
NIDCD Primary Objective 2	Up to 6 years post-implant period	To enable communication via synthesized speech decoded from neural signals.

Secondary Outcome Measures

Name	Time	Method
NIDCD Secondary Objective 1	Up to 6 years post-implant period	To evaluate communication via text decoded from neural signals.
NIDCD Secondary Objective 2	Up to 6 years post-implant period	To evaluate communication via synthesized speech decoded from neural signals.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States