No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 – 70
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
3 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for people with conditions like ALS, tetraplegia, or locked-in syndrome. Participants will have a device implanted in their brain to help with communication and movement for six months.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with tetraplegia, ALS, or locked-in syndrome.
My condition started at least one year ago.
I am between 22 and 70 years old.
I can communicate reliably, like through eye movement.
I am willing to provide informed consent.
I have a stable support system from caregivers.
I can travel up to 100 miles to the study location.
I can follow study instructions.
You may not be able to join if
I have significant psychiatric conditions that affect my participation.
I have attempted suicide or thought about it in the past year.
I have medical conditions that make surgery unsafe.
I have an implanted device that is not safe for MRI.
I am currently pregnant or nursing an infant.
I have active infections or unexplained fever.
I cannot stop anti-coagulant medications during surgery.
I have chronic conditions that interfere with participation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode sp…
The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS)
* Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment
* Complete or incomplete te…
Inclusion Criteria:
* Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS)
* Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment
* Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), or severe ataxia. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in LIS.
* 22-70 years
* Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants
* Ability to communicate reliably, such as through eye movement
* Willingness and ability to provide informed consent
* Screened by rehabilitation psychologist with a result showing that the participant has a stable psychosocial support system with caregiver capable of monitoring participant throughout the study
* Ability and willingness to travel up to 100 miles to study location up to three days per week for the duration of the study
* Ability to understand and comply with study session instructions
* Participant consents to the study and still wishes to participate at the time of the study
Exclusion Criteria:
* Performance on formal neuropsychological testing that indicates significant psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.
* Suicide attempt or persistent suicidal ideation within the past 12 months.
* Implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants.
* History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months
* Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease/disorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation)
* Other chronic, unstable medical conditions that could interfere with subject participation.
* Presence of pre-surgical findings in anatomical, functional, and/or vascular neuroimaging that makes achieving implant locations within desired risk levels too challenging (to be decided by neurological and neurosurgical team)
* Prior cranioplasty
* Inability to undergo MRI or anticipated need for an MRI during the study period
* Participants with active infections or unexplained fever
* Participants with other morbid conditions making the implantation of the recording elements unsafe; not limited to: significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe
* Pregnancy (confirmation through blood test)
* Nursing an infant, planning to become pregnant, or not using adequate birth control
* Corrected vision poorer than 20/100
* HIV or AIDS infection
* Existing scalp lesions or skin breakdown
* Chronic oral or intravenous use of steroids or immunosuppressive therapy
* Active cancer within the past year or requires chemotherapy
* Uncontrolled autonomic dysreflexia within the past 3 months
* Hydrocephalus with or without an implanted ventricular shunt
* Participants in whom it is medically contraindicated to stop anti-coagulant medications during surgery
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