Clinical trial NCT04635657: Cognitive Status After Removal of Skull Base Meningioma
Official title: Pre and Post-Operative Cognitive Status in Patients Undergoing Surgery for Resection of Meningioma Associated With the Frontal and Temporal Lobes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Meningioma
Skull Base Meningioma
Frontal Meningioma
Temporal Meningioma
Cognitive Impairment
Cognitive Decline
Post-Surgical Cognition
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: This study will look at patients who are undergoing resection of a skull based meningioma, located in the frontal or temporal lobe, via craniotomy or via endoscopic endonasal approach. The study will compare cognitive function at baseline, at six weeks postoperatively and at one year postoperatively. The cognitive testing being done at baseline will be a clinical care set of assessments done by the speech language pathology team and will include the RBANS tests, the MoCA, PROMIS-29, and NeuroQOL-Cognitive Functions.

Eligibility criteria: Inclusion Criteria:

* 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
* Previous surgery will not exclude the patient as a new baseline cognitive evaluation will occur.

Exclusion Criteria:

* Patient is a prisoner
* Patient is 90 years of age or older
* Pregnant women
* Previous radiation to the brain

Primary outcomes:
measure: Overall cognitive function
timeFrame: 12 months
Secondary outcomes:
measure: Cognitive function based on surgical approach using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 12 months
measure: Cognitive function based on tumor location using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 12 months
Other outcomes:
measure: Surgical comorbidities based on quality of life questionnaire PROMIS-29
timeFrame: 12 months
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Daniel Prevedello, MD
role: PRINCIPAL_INVESTIGATOR
References: