Last updated on May 2020

Wise Cortical Strip for Intraoperative Neurophysiological Monitoring

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Brain Tumor Adult | Seizure Disorders | Seizure Disorders (Pediatric) | Epilepsy
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Brain tumor or epilepsy that require neurosurgical intervention and exposure of the central region of the cerebral cortex including at least the hand-forearm areas in the primary motor cortex and the primary somatosensory cortex (i.e. excision of lesion, open approach)
  • Age: 18 - 75 years at the time of enrollment
  • Required intraoperative neurophysiological monitoring with subdural electrodes
  • Willingness to provide informed consent for participating in the study

Exclusion Criteria:

  • Significant psychiatric impairments which, in the opinion of the investigator, will interfere with the proper administration or completion of the protocol
  • Acute or untreated infections (viral, bacterial or fungal)
  • Currently on any anticoagulant medication that cannot be discontinued during the perioperative period, or patients with factor XIII deficiency or any other hematological disease
  • Current treatment with antibiotics
  • Patients with a previous a craniotomy within the vicinity of the central region
  • A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or not using adequate contraception.
  • A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival
  • Current use or a recent history of illicit drug(s) use or alcohol abuse (defined as frequent or daily consumption of more than four alcoholic drinks per day)
  • Active participation in another investigational device study
  • Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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