Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
NCT Number: NCT04536142
This study is being done to see the changes in structural and functional connectivity that happen in the brain of patients undergoing brain tumor surgery.
Looking for future studies?
Notify Me19 year and older
All sexes
Observational
Omaha, Nebraska, 68198, United States
The purpose of this study is to visualize and quantify changes in the brain of patients undergoing brain tumor surgery through high-quality, high-resolution structural and functional brain imaging and brain connectivity measures. To understand the effects of the primary treatment for brain tumors, the investigators will determine changes in brain connectivity after surgery and correlate this with neurologic status. The investigators will prospectively collect brain imaging (MRI) and clinical data in brain tumor patients before and after removal of their tumor. Any adult patient with a brain tumor (primary or metastatic) for whom surgery to remove the tumor is planned is eligible. The investigators plan for recruitment of 30 subjects. This will include 27 subjects with brain tumors and 3 healthy controls. Both clinical and imaging data will be collected for tumor and healthy subjects. A two-part research scan (diffusion MRI and resting state functional MRI) will be performed within 1 week prior to surgery and again 2 weeks after surgery. The healthy controls will obtain identical research scans with the second session two weeks following the first session. Subjects will be also administered Neurocognitive and Qualitative Assessments at two time intervals, pre- and post-surgery (2 weeks).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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.
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.
University of Nebraska
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02153957
Behavior, Brain Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT02851706
Astrocytoma, Brain Cancer
Bethesda, Maryland, United States
View Trial DetailsNCT06368310
Brain Diseases, Brain Neoplasms
Salford, Greater Manchester, United Kingdom
View Trial DetailsNCT05776602
Brain Diseases, Brain Neoplasms
Stockholm, Stockholm County, Sweden
View Trial Details