Cognitive Status After Removal of Skull Base Meningioma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Long-term Cognitive testing.
- Who it may be relevant to
- Registry conditions: Meningioma, Skull Base Meningioma, Frontal Meningioma, Temporal Meningioma. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pre and Post-Operative Cognitive Status in Patients Undergoing Surgery for Resection of Meningioma Associated With the Frontal and Temporal Lobes
Overview
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.
Interventions
- 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.
Primary outcome measures
- Overall cognitive function [Time frame: 12 months]
Secondary outcome measures (2)
- Cognitive function based on surgical approach using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Time frame: 12 months]
- Cognitive function based on tumor location using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Ohio State University Wexner Medical Center — Columbus
Identifiers
NCT: NCT04635657 · 2019H0340