Cognitive Status After Removal of Skull Base Meningioma

Pre and Post-Operative Cognitive Status in Patients Undergoing Surgery for Resection of Meningioma Associated With the Frontal and Temporal Lobes

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Cognitive Decline; Meningioma; Skull Base Meningioma; Frontal Meningioma; Temporal Meningioma; Post-Surgical Cognition
• Intervention / Treatment: Other: Long-term Cognitive testing

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Uchechi Okafor, BS; Phone Number: 614-293-4876; Email: Uchechi.Okafor@osumc.edu
• Study Contact Backup: Name: Emma Kurtz, BS; Phone Number: (614) 685-4534; Email: Emma.Kurtz@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Wexner Medical Center
      • Principal Investigator: Daniel Prevdello, MD
      • Contact: Uchechi Okafor, BS; Phone Number: 614-293-4876; Email: Uchechi.Okafor@osumc.edu
      • Contact: Emma Kurtz, BS; Phone Number: (614) 685-4534; Email: Emma.Kurtz@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Meningioma Group; This group will include all patients in the study, regardless of location (frontal or temporal lobe) or surgical approach (endoscopic endonasal or craniotomy). Fifty patients will be included in the cohort	Other: Long-term Cognitive testing; These patients will undergo their standard of care cognitive testing at baseline, six weeks post-operatively and one year post-operatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall cognitive function	Cognitive function will be compared at baseline and at one year post-operatively.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Daniel Prevedello, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neurocognitive Disorders; Cognition Disorders; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Cognitive Dysfunction; Meningioma
• Other Study ID Numbers: 2019H0340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There will not be sharing of individual participant data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No