INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study

Exclusion Criteria14

• Active infection or unexplained fever in the 48 hours prior to informed consent.
• Major psychiatric disorder that may adversely impact the participant's safety or study compliance, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.
• Diagnosis of ALS-FTD or another dementia.
• Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).
• Known allergy to patient-contacting materials included in the implanted device.
• Contraindication to angiographic imaging or iodine contrast media.
• History of central venous sinus thrombosis.
• Recent history of new venous thromboembolic event (in the 6 months prior to implant), recurrent history of venous thromboembolic disease, or hypercoagulable state.
• Contraindication to antithrombotic therapy.
• Participant is at substantially increased risk of infection, including immunocompromised status, recurrent or chronic infection, or poorly controlled diabetes mellitus.
• Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.
• Pregnant or breast feeding.
• Patients who are currently enrolled in any other clinical trial that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements.
• Any other disease or disorder that could significantly affect participation in the study. Examples may include corrected vision insufficient for viewing computer screens or hearing insufficient for following verbal instructions, which might impact the participant's ability to participate in BCI training and testing.