Assessing cognitive outcomes after skull base meningioma surgery
Pre and Post-Operative Cognitive Status in Patients Undergoing Surgery for Resection of Meningioma Associated With the Frontal and Temporal Lobes
Ohio State University · NCT04635657
This study is testing how surgery for removing skull base meningiomas affects thinking and memory in patients over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Ohio State University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT04635657 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term cognitive outcomes of patients who undergo surgery for the removal of skull base meningiomas located in the frontal or temporal lobes. Participants will be assessed for cognitive function at baseline, six weeks post-surgery, and one year post-surgery using a series of standardized cognitive tests administered by a speech language pathology team. The study will utilize assessments such as the RBANS tests, MoCA, PROMIS-29, and NeuroQOL-Cognitive Functions to measure changes in cognitive status over time.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older scheduled for surgery to remove a frontal or temporal lobe meningioma.
Not a fit: Patients who are prisoners, over 90 years old, pregnant, or have had previous radiation to the brain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the cognitive impacts of meningioma surgery, potentially guiding postoperative care and rehabilitation strategies.
How similar studies have performed: While cognitive outcomes after meningioma surgery have been studied, this specific approach focusing on long-term cognitive assessment post-surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- Ohio State University Wexner Medical Center — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel Prevedello, MD — Ohio State University
- Study coordinator: Megan Frost, BS
- Email: Megan.Frost@osumc.edu
- Phone: 614-685-8622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Meningioma, Skull Base Meningioma, Frontal Meningioma, Temporal Meningioma, Cognitive Impairment, Cognitive Decline, Post-Surgical Cognition