Cognitive Status After Removal of Skull Base Meningioma

NCT04635657 | Unknown

• 1 other identifier: 2019H0340
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningioma; Skull Base Meningioma; Frontal Meningioma; Temporal Meningioma; Cognitive Impairment; Cognitive Decline; Post-Surgical Cognition

Outcome Measures

Primary Outcomes (1)

• Overall cognitive function

  Cognitive function will be compared at baseline and at one year post-operatively.

  12 months

Secondary Outcomes (2)

• Cognitive function based on surgical approach using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  12 months

• Cognitive function based on tumor location using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  12 months

Other Outcomes (1)

• Surgical comorbidities based on quality of life questionnaire PROMIS-29

  12 months

Study Arms (1)

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

Interventions

Long-term Cognitive testing OTHER

These patients will undergo their standard of care cognitive testing at baseline, six weeks post-operatively and one year post-operatively.

Meningioma Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Meningioma; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Daniel Prevedello, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Frost, BS

CONTACT

614-685-8622; Megan.Frost@osumc.edu

Uchechi Okafor, BS

CONTACT

614-293-4876; Uchechi.Okafor@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: November 19, 2020
• Study Start: December 10, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)