MeningiomaNCT04635657
Cognitive Status After Removal of Skull Base Meningioma
An observational study of Meningioma and Skull Base Meningioma, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Meningioma, Skull Base Meningioma, Frontal Meningioma
- What is being tested?
- Long-term Cognitive testing
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- Patient is a prisoner
- Patient is 90 years of age or older
- Pregnant women
- Previous radiation to the brain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Emma Kurtz, BS, (614) 685-4534, Emma.Kurtz@osumc.edu
Uchechi Okafor, BS, 614-293-4876, Uchechi.Okafor@osumc.edu
About this study
Official title: Pre and Post-Operative Cognitive Status in Patients Undergoing Surgery for Resection of Meningioma Associated With the Frontal and Temporal Lobes
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.
Read the 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.
- Conditions
- Meningioma, Skull Base Meningioma, Frontal Meningioma, Temporal Meningioma, Cognitive Impairment, Cognitive Decline
- Being tested
- Long-term Cognitive testing
- Medical subject headings
- Meningioma, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term Cognitive testingOther
These patients will undergo their standard of care cognitive testing at baseline, six weeks post-operatively and one year post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Long-term Cognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cognitive function
Cognitive function will be compared at baseline and at one year post-operatively.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start10 Dec 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel M. Prevedello, Ohio State University
- Investigators
- Daniel Prevedello, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635657
- Sponsor's protocol ID
- 2019H0340
- Status last verified
- May 2026
- First submitted
- 29 Sep 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will not be sharing of individual participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre and Post-Operative Cognitive Status in Patients Undergoing Surgery for Resection of Meningioma Associated With the Frontal and Temporal Lobes
- ClinicalTrials.gov ID
- NCT04635657
- Acronym / sponsor ID
- 2019H0340
- Conditions
- Meningioma, Skull Base Meningioma, Frontal Meningioma, Temporal Meningioma, Cognitive Impairment, Cognitive Decline
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meningioma Group | – | Other: Long-term Cognitive testingThis 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Patient is a prisoner
- Patient is 90 years of age or older
- Pregnant women
- Previous radiation to the brain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-term Cognitive testingThese patients will undergo their standard of care cognitive testing at baseline, six weeks post-operatively and one year post-operatively. | Other | Meningioma Group |
Primary outcome
Overall cognitive function
Time frame: 12 months
Cognitive function will be compared at baseline and at one year post-operatively.
2 secondary outcomes
Cognitive function based on surgical approach using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: 12 months
Cognitive function based on tumor location using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. There will not be sharing of individual participant data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Prevedello, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningioma and Skull Base Meningioma, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Kurtz, BS ((614) 685-4534, Emma.Kurtz@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall cognitive function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.