Clinical trial for ALS
Official title ECoG BMI for Motor and Speech Control
ClinicalTrials.gov ID: NCT03698149
What this study is testing
- What it's testing
- The study wants to find out if electrocorticography (ECoG) signals can be used to operate complex devices for motor and speech control.
- Who it's for
- Adults who have severe ALS, spinal cord injury, stroke, multiple sclerosis, or muscular dystrophies.
- What's involved
- Participants will have small electrodes placed on the surface of the brain to record ECoG signals and will try to use those signals to control devices, with regular monitoring and tests.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Age \> 21
- Limited ability to use upper limbs, based on neurological examination, due to stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis...
- 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...
- 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
You likely can't join if
- 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...
- History of suicide attempt or suicidal ideation
See the full eligibility 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...
- 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
- 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.
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.