Cognitive Status After Removal of Skull Base Meningioma

NCT ID: NCT04635657

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-10

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Long-term Cognitive testing

Intervention Type OTHER

These patients will undergo their standard of care cognitive testing at baseline, six weeks post-operatively and one year post-operatively.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Daniel M. Prevedello

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Prevedello, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan Frost, BS

Role: CONTACT

614-685-8622

Uchechi Okafor, BS

Role: CONTACT

614-293-4876

Facility Contacts

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Megan Frost, BS

Role: primary

614-685-8622

Uchechi Okafor, BS

Role: backup

614-293-4876

Other Identifiers

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2019H0340

Identifier Type: -

Identifier Source: org_study_id

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