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Clinical Trials/NCT04635657
NCT04635657
Recruiting
N/A

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

Ohio State University1 site in 1 country50 target enrollmentDecember 10, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Meningioma
Sponsor
Ohio State University
Enrollment
50
Locations
1
Primary Endpoint
Overall cognitive function
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2019
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel M. Prevedello

Clinical Professor

Ohio State University

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

Outcomes

Primary Outcomes

Overall cognitive function

Time Frame: 12 months

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

Secondary Outcomes

  • Cognitive function based on tumor location using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(12 months)
  • Cognitive function based on surgical approach using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(12 months)

Study Sites (1)

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