Evaluation of Changes in Brain Connectivity After Tumor Resection
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ClinicalTrials.gov Identifier: NCT04536142 |
Recruitment Status :
Recruiting
First Posted : September 2, 2020
Last Update Posted : September 28, 2021
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Condition or disease | Intervention/treatment |
---|---|
Brain Tumor | Diagnostic Test: MRI Diagnostic Test: neuropsychological tests and qualitative assessment |
Study Type : | Observational |
Estimated Enrollment : | 30 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Evaluation of Changes in Brain Connectivity After Tumor Resection |
Actual Study Start Date : | August 27, 2020 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | June 30, 2022 |

Group/Cohort | Intervention/treatment |
---|---|
Brain tumors
Subjects with operable supratentorial brain tumors
|
Diagnostic Test: MRI
A research MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery. The surgical removal of the brain tumor(s) is not a component of this research. The MRI scan will perform both programs (diffusion MRI, resting state MRI) during the same single session. The healthy controls will obtain identical research scans with the second session between two and three weeks following the first session, since they will not undergo a surgery. Diagnostic Test: neuropsychological tests and qualitative assessment Neuropsych Tests: COWA, Trails, RCFT, RAVLT, WMS-III subtests, NAB Digits, Grooved Pegboard, Stroop Color Word Test, verbal and spatial working memory, WRAT-IV, Word Reading subtest. Standardized quality of life measures: MDASI-BT, FACT-Br, FrSBe |
Healthy subjects
Healthy subjects
|
Diagnostic Test: MRI
A research MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery. The surgical removal of the brain tumor(s) is not a component of this research. The MRI scan will perform both programs (diffusion MRI, resting state MRI) during the same single session. The healthy controls will obtain identical research scans with the second session between two and three weeks following the first session, since they will not undergo a surgery. Diagnostic Test: neuropsychological tests and qualitative assessment Neuropsych Tests: COWA, Trails, RCFT, RAVLT, WMS-III subtests, NAB Digits, Grooved Pegboard, Stroop Color Word Test, verbal and spatial working memory, WRAT-IV, Word Reading subtest. Standardized quality of life measures: MDASI-BT, FACT-Br, FrSBe |
- Brain connectivity changes [ Time Frame: MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery. ]With both the functional and structural connectomes created, the investigators will compute graph network measures before and after surgical resection and assess both nodal and global network measures.
- Neurocognitive changes [ Time Frame: Cognitive tests will be performed within 1 week prior to surgery and again 2 weeks after surgery. ]
Meyers Neuropsychological Battery: Published reliable change indices (RCI) will be used to control for practice effects between the assessment points for all Meyers Neuropsychological Battery (MNB) subtests.
QOL inventories: Differences in scores at baseline, relative to treatment phase, will be calculated.

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
-
Brain tumor subjects (27)
- informed consent
- age equal to or greater than 19 years (age of majority in Nebraska)
- brain tumor that requires surgery
- primary or metastatic brain tumor
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Healthy subjects (3)
- informed consent
- age equal to or greater than 19 years (age of majority in Nebraska)
- healthy subject with no know neurocognitive deficiencies
Exclusion Criteria:
- any contraindication to MRI (i.e. implanted devices)
- inappropriate body habitus for MRI
- no capacity to understand the study the study or consent to it
- positive pregnancy test in females
- end stage renal disease or severe renal dysfunction
- severe anxiety disorder
- metabolic encephalopathy
- significant medical co-morbidities precluding a safe surgery
- need for sedation for MRI

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04536142
Contact: Dulce Maroni, PhD | 402.836.9751 | dmaroni@unmc.edu |
United States, Nebraska | |
UNMC/Nebraska Medicine | Recruiting |
Omaha, Nebraska, United States, 68198 | |
Contact: Dulce Maroni, PhD 402-836-9751 dmaroni@unmc.edu |
Principal Investigator: | Michele Aizenberg, MD | University of Nebraska |
Responsible Party: | Michele Aizenberg, MD, Professor, Neurosurgery, Director Brain and Spine Cancer Center, University of Nebraska |
ClinicalTrials.gov Identifier: | NCT04536142 |
Other Study ID Numbers: |
155-20-EP |
First Posted: | September 2, 2020 Key Record Dates |
Last Update Posted: | September 28, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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