Cognitive Status After Removal of Skull Base Meningioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 89 Years
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04635657
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ohio State University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Daniel Prevedello, MD
Principal Investigator Affiliation	Ohio State University Wexner Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Meningioma, Skull Base Meningioma, Frontal Meningioma, Temporal Meningioma, Cognitive Impairment, Cognitive Decline, Post-Surgical Cognition

Additional Details

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.

Arms & Interventions

Arms

: Meningioma Group

This group will include all patients in the study, regardless of location (frontal or temporal lobe) or surgical approach (endoscopic endonasal or craniotomy). Fifty patients will be included in the cohort

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbus, Ohio

Status

Recruiting

Address

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

Site Contact

Megan Frost, BS

[email protected]

614-685-8622

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