ECoG BMI for Motor and Speech Control
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorKarunesh Ganguly
About this trial
Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy or breastfeeding
Inability to understand and/or read English
Inability to give consent
Dementia, based on history, physical exam, and MMSE
Trial design
Design model
Single group
Treatments tested in this trial
PMT/Blackrock Combination Device
DevicePMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Electrocorticography-based brain computer interfaceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 6 years post-implant period2
NIDCD Primary Objective 1
To enable communication via text decoded from neural signals.
Time frame
Up to 6 years post-implant period3
NIDCD Primary Objective 2
To enable communication via synthesized speech decoded from neural signals.
Time frame
Up to 6 years post-implant periodSecondary outcomes
1
NIDCD Secondary Objective 1
To evaluate communication via text decoded from neural signals.
Time frame
Up to 6 years post-implant period2
NIDCD Secondary Objective 2
To evaluate communication via synthesized speech decoded from neural signals.
Time frame
Up to 6 years post-implant periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karunesh Ganguly
Lead sponsor
University of California, San Francisco
Sponsor institution
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov