ECoG for Motor and Speech Control (BRAVO)

Study Purpose:

Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.

Disease:

Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS, Primary Lateral Sclerosis (PLS),

Study Type:

Interventional Trial

Study Category:

Device

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Karunesh Ganguly, MD, PhD University of California, San Francisco

Edward Chang, MD University of California, San Francisco

Clinicaltrials.gov ID (11 digit #):

NCT03698149

Neals Affiliated?

Coordinating Center Contact Information

University of California, San Francisco
Adelyn Tu-Chan / .(JavaScript must be enabled to view this email address) / (415) 575-0431
.(JavaScript must be enabled to view this email address) 505 Parnassus Ave
San Francisco, California 94158 United States

Full Study Summary:

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 Sponsor:

University of California, San Francisco

Participant Duration:

Estimated Enrollment:

Estimated Study Start Date:

11/09/2018

Estimated Study Completion Date:

08/15/2030

Posting Last Modified Date:

Date Study Added to alsconsortium.org:

08/02/2021

Eligibility Criteria
Gender:
Female, Male
Minimum Age:
21
Maximum Age:
N/A

Time since Symptom Onset:
N/A
Time since Diagnosis:
N/A
Can participants use Riluzole?
Yes
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)
Site Contact Information

University of California, San Francisco
Adelyn Tu-Chan / .(JavaScript must be enabled to view this email address) / (415) 575-0431
San Francisco, California 94158
United States