Investigation on the Cortical Communication (CortiCom) System

Launched by JOHNS HOPKINS UNIVERSITY · Jun 12, 2018

Keywords

ClinConnect Summary

The Cortical Communication (CortiCom) System trial is studying a new way to help people with severe movement and speech challenges due to conditions like tetraplegia, Locked-in Syndrome, brainstem stroke, and amyotrophic lateral sclerosis (ALS). The system involves implanting small grids in the brain that can pick up signals related to speech and movement. This could potentially allow participants to communicate better and regain some control over their movements. The study is currently looking for participants aged 22 to 70 who have been diagnosed with one of these conditions at least a year ago, can communicate reliably (like through eye movements), and are generally healthy enough for surgery.

If someone is eligible and decides to participate, they can expect to have the grids implanted in their brain for about six months. They will need to visit the study location up to three times a week during this time and follow specific instructions. It’s important for participants to have support from caregivers and to be able to understand the study’s requirements. The trial has certain health and safety criteria that could exclude some individuals, such as those with specific medical conditions or those who are pregnant. Overall, this study aims to explore innovative ways to improve communication for individuals facing significant physical challenges.

Gender

ALL

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 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