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New treatment option for Tetraplegia
Official title Investigation on the Cortical Communication (CortiCom) System
ClinicalTrials.gov ID: NCT03567213
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- 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...
- 22-70 years
- Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary...
You likely can't join if
- Performance on formal neuropsychological testing that indicates significant psychiatric conditions or cognitive impairments that would interfere with...
- 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...
- 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...
- Other chronic, unstable medical conditions that could interfere with subject participation.
See the full eligibility criteria
Who can join
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, 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 - 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, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.