Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT04635657

Conditions

Meningioma

Skull Base Meningioma

Frontal Meningioma

Temporal Meningioma

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Long-term Cognitive testing

Study Details

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

Study ID

NCT04635657

Start date

Dec 10, 2019

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • Overall cognitive function [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Daniel Prevdello, MD

More Information

Sponsor

Ohio State University

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-05-22.