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A Study to Understand the Patients’ Perioperative Experiences of Awake Craniotomies
Jacksonville, FL
This study seeks to understand the patient perceptions of awake craniotomies.
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CraniSeal Post Approval Study
Jacksonville, FL; Rochester, MN
To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.
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A Study to Evaluate a Handheld Dynamometer During Awake Craniotomy
Jacksonville, FL
The primary purpose of this study is to assess the feasibility, safety and reliability of the use of handheld dynamometry in evaluating intraoperative motor function for patients undergoing awake craniotomy for the resection of glioma located within or adjacent to the motor cortex.
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Patients and Clinicians in Their Journey Through Awake Craniotomy and Spine Surgery
Jacksonville, FL
The purpose of this research is to gain an in-depth understanding of the patient and clinician’s journey for awake neurosurgical spine and craniotomy cases, spanning from diagnosis through recovery. This study serves as a foundational initiative supporting the establishment of a destination center at Mayo Clinic Florida for awake neurosurgery procedures.
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A Study of Using Magnetic Resonance Elastography to Measure Stiffness (mechanical properties) of the Meningioma and Other Brain Tumors Similar to Meningiomas
Rochester, MN
The purpose of this study is to demonstrate improved planning for meningioma and similar brain tumor surgery.
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Novel Circular Grid for Electrocorticography During Awake Craniotomy for Glioma Resection
Jacksonville, FL
We will be comparing circular grid to a strip electrode to record electrocorticography.
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Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
Jacksonville, FL
The purpose of this study is to compare local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).
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Effects of Cognitive Function, Post-op Fatigue and Quality of Life Comparing General vs Regional Anesthesia for Non-eloquent Brain Tumors Resection
Jacksonville, FL
The aim of the study is to create a registry to prospectively collect pre-operative, during surgery and post-operative data, questionaries will assess (at baseline before the surgery, 3-4 weeks, and at 3-6 months) cognitive function, assessed with a Mini-mental State Examination (MMSE), PROMIS Fatigue 7a form, quality of life (QoL), assessed using the SF-12 questionnaire, quality of sleep assessed using PROMIS Sleep disturbance 7a form (1 week after surgery).
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A Study to Test Concussion Return to Baseline after Elective Craniotomy Procedure
Jacksonville, FL
The purpose of this study is to determine return to baseline (RTB) period after an elective craniotomy procedure using the ImPACT testing assessment.
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A Study to Use a Patient Monitoring Application that Monitors Physiological Data, Psychosocial Data, and Responses to Survey Questions in Patients Undergoing Cranial or Spinal Surgery
Rochester, MN
The purpose of this study is to use a patient monitoring application that monitors physiological data, psychosocial data, and responses to survey questions collected during a one month pre and three and six month postoperative observation period.