ECoG for Motor and Speech Control (BRAVO)

Printer-Friendly      

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.

Study Status:

Recruiting

Disease:

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

Study Type:

Interventional

Type of Intervention:

Device

Intervention Name:

Device: PMT/Blackrock Combination Device

Placebo:

Phase:

N/A

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:

NCT03698149

Neals Affiliated?

No

Coordinating Center Contact Information

University of California, San Francisco

Adelyn Tu-Chan / email hidden; JavaScript is required / (415) 575-0431

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

Estimated Enrollment:

8

Estimated Study Start Date:

11 / 09 / 2018

Estimated Study Completion Date:

08 / 15 / 2030

Date Study Added to neals.org:

08 / 02 / 2021

Minimum Age:

21

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)

University of California, San Francisco

Adelyn Tu-Chan / (415) 575-0431 / email hidden; JavaScript is required

San Francisco, California 94158
United States