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Completed

NCT Number: NCT04536142

Evaluation of Changes in Brain Connectivity After Tumor Resection

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

MRI

Diagnostic Test

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.

neuropsychological tests and qualitative assessment

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Great Plains IDeA-CTR

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2020
Registry last updated
Sep 29, 2023

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.

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