Cognitive Status After Removal of Skull Base Meningioma

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04635657
• Other study ID #: 2019H0340
• Status: Recruiting
• Start date: December 10, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: Megan Frost, BS
• Phone: 614-685-8622
• Email: Megan.Frost[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical comorbidities based on quality of life questionnaire PROMIS-29	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.	12 months
Primary	Overall cognitive function	Cognitive function will be compared at baseline and at one year post-operatively.	12 months
Secondary	Cognitive function based on surgical approach using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Patients divided by approach and overall cognitive function will be evaluated.	12 months
Secondary	Cognitive function based on tumor location using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Patients will be divided by tumor location and cognitive function will be evaluated.	12 months