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NCT Number: NCT04635657

Cognitive Status After Removal of Skull Base Meningioma

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.

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Key information

Conditions

Meningioma Central Nervous System Neoplasms Cognition Disorders Cognitive Decline Cognitive Dysfunction Cognitive Impairment Frontal Meningioma Meningeal Neoplasms Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neurocognitive Disorders Post-Surgical Cognition Skull Base Meningioma Temporal Meningioma

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Overall cognitive function

    Time frame: 12 months

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

Secondary outcomes

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

    Time frame: 12 months

    Patients divided by approach and overall cognitive function will be evaluated.

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

    Time frame: 12 months

    Patients will be divided by tumor location and cognitive function will be evaluated.

Other outcomes

  1. Surgical comorbidities based on quality of life questionnaire PROMIS-29

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Kurtz, BS

CONTACT

[email protected]

(614) 685-4534

Uchechi Okafor, BS

CONTACT

[email protected]

614-293-4876

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Nov 19, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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