Cognitive Status After Removal of Skull Base Meningioma

Recruiting

• Conditions: Meningioma; Temporal Meningioma; Post-Surgical Cognition; Skull Base Meningioma; Frontal Meningioma; Cognitive Impairment; Cognitive Decline
• Interventions: Other: Long-term Cognitive testing

• Registration Number: NCT04635657
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-22
• Last Update Posted: 2023-10-24
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Meningioma Group	Long-term Cognitive testing	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

Primary Outcome Measures

Name	Time	Method
Overall cognitive function	12 months	Cognitive function will be compared at baseline and at one year post-operatively.

Secondary Outcome Measures

Name	Time	Method
Cognitive function based on tumor location using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	12 months	Patients will be divided by tumor location and cognitive function will be evaluated.
Cognitive function based on surgical approach using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	12 months	Patients divided by approach and overall cognitive function will be evaluated.

Trial Locations

Locations (1)

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States