Amyotrophic Lateral Sclerosis Clinical Trial
— CortiComOfficial title:
Investigation on the Cortical Communication (CortiCom) System
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.
Status | Recruiting |
Enrollment | 3 |
Est. completion date | August 31, 2026 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Medicine | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to device explantation | This study outcome will be considered successful if the device is not explanted during the 26-week period of the study. Explantation of the device prior to the completion of the 26-week period implies that the device is putting the subject at risk (e.g. through a serious infection at the implantation site) and therefore must be removed. | 26 weeks | |
Secondary | Success rate in controlling the brain computer interface, i.e. ratio of successful trials to total trials. | One or more participants demonstrates successful use of the CortiCom system in which motor and/or speech neural signals can be decoded to provide control signals for software and devices. Efficacy is assessed in terms of accuracy, i.e. how often the participant is able to select a desired target. | 26 weeks | |
Secondary | Speed of brain-computer interface control, i.e. time to complete successful trials (in seconds). | One or more participants demonstrates successful use of the CortiCom system in which motor and/or speech neural signals can be decoded to provide control signals for software and devices. Efficacy is therefore also assessed in terms of how long it takes to select the target. | 26 weeks |
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