Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04635657 | RECRUITING | Meningioma

Cognitive Status After Removal of Skull Base Meningioma
Sponsor:

Ohio State University

Information provided by (Responsible Party):

Daniel M. Provvello

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.

Condition or disease

Meningioma

Skull Base Meningioma

Frontal Meningioma

Temporal Meningioma

Cognitive Impairment

Cognitive Decline

Post-Surgical Cognition

Intervention/treatment

Long-term Cognitive testing

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 50 participants
Official Title : Pre and Post-Operative Cognitive Status in Patients Undergoing Surgery for Resection of Meningioma Associated With the Frontal and Temporal Lobes
Actual Study Start Date : 2019-12-10
Estimated Primary Completion Date : 2024-12-31
Estimated Study Completion Date : 2024-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 89 Years
Sexes Eligible for Study: ALL
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
Cognitive Status After Removal of Skull Base Meningioma

Location Details

NCT04635657

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Ohio

Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210