About this trial
The purpose of this prospectively enrolling trial is to assess long-term cognitive outcomes of patients undergoing surgery for resection of a meningioma associated with the frontal and temporal lobes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject has a meningioma associated with the frontal or temporal lobes
Subject is scheduled to undergo open craniotomy or Endoscopic Endonasal surgery
Subject is 18 years of age or older
The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
Disqualifiers
Patient is a prisoner
Patient is 90 years of age or older
Pregnant women
Previous radiation to the brain
Trial population
Patients between 18 years of age and 89 years of age will be eligible for this study. Patients undergoing a resection of a meningioma located in the frontal or temporal lobes via craniotomy or endoscopic endonasal surgery for clinical purposes will be included. Should a patient have a previous surgical removal of a meningioma, they will still be included. However, all patients having undergone previous radiation to the brain, for any reason, will not be included in the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Long-term Cognitive testing
Other interventionThese patients will undergo their standard of care cognitive testing at baseline, six weeks post-operatively and one year post-operatively.
Treatment groups
Trial outcomes
Primary outcomes
Overall cognitive function
Cognitive function will be compared at baseline and at one year post-operatively.
Secondary outcomes
Cognitive function based on surgical approach using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Patients divided by approach and overall cognitive function will be evaluated.
Cognitive function based on tumor location using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Patients will be divided by tumor location and cognitive function will be evaluated.
Other outcomes
Surgical comorbidities based on quality of life questionnaire PROMIS-29
Assessment of preoperative and postoperative comorbidities and their effects on cognitive function post-operatively. Co-morbidities will be based on clinical outcomes evaluated by the primary investigator, co-investigators and the speech language pathology team.
Sponsors and contacts
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