Testing Stentrode for neurologic disorder

Exclusion

• −Known allergy to patient-contacting materials included in the implanted device (listed in Physician Implant Manual).
• −Unrealistic expectations regarding the potential benefits of the device, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →(s).
• −Active infection or unexplained fever in the 48 hours prior to informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
• −Major psychiatric disorder that may adversely impact the participant's safety or study compliance (e.g., severe depression, psychotic features, personality disorder, severe emotional lability, substance abuse), in the opinion of the Investigator(s).
• −Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities, in the opinion of the Investigator(s).
• −Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).
• −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) or recurrent history of venous thromboembolic disease.
• −Contraindication to antithrombotic therapy, in the opinion of the Investigator(s).
• −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.
• −Currently receiving or expected to require medical treatment that may be precluded by device implant, including magnetic resonance imaging, transcranial magnetic stimulation, electroconvulsive therapy, transcranial ultrasound, shortwave, microwave, and/or therapeutic ultrasound diathermy, or balloon angioplasty or stenting in the target vessel.
• −Patients who are currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in any other clinical trialInterventional studyA study where participants are given something to see what happens.Read more → that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements.
• −Patients with ALS due to SOD1 mutations on gene therapy.
• −Any other disease or disorder that could significantly affect participation in the study, in the opinion of the Investigator(s). 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.
• −Pregnant or breast feeding.