Cognitive Status After Removal of Skull Base Meningioma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient is a prisoner

Patient is 90 years of age or older

Pregnant women

Previous radiation to the brain

Trial population

Patients between 18 years of age and 89 years of age will be eligible for this study. Patients undergoing a resection of a meningioma located in the frontal or temporal lobes via craniotomy or endoscopic endonasal surgery for clinical purposes will be included. Should a patient have a previous surgical removal of a meningioma, they will still be included. However, all patients having undergone previous radiation to the brain, for any reason, will not be included in the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Long-term Cognitive testing

    Other intervention

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Meningioma Group1 intervention

Trial outcomes

Primary outcomes

1

Overall cognitive function

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

Time frame
12 months

Secondary outcomes

1

Cognitive function based on surgical approach using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Patients divided by approach and overall cognitive function will be evaluated.

Time frame
12 months
2

Cognitive function based on tumor location using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Patients will be divided by tumor location and cognitive function will be evaluated.

Time frame
12 months

Other outcomes

1

Surgical comorbidities based on quality of life questionnaire PROMIS-29

Assessment of preoperative and postoperative comorbidities and their effects on cognitive function post-operatively. Co-morbidities will be based on clinical outcomes evaluated by the primary investigator, co-investigators and the speech language pathology team.

Time frame
12 months

Sponsors and contacts

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