Evaluation of Changes in Brain Connectivity After Tumor Resection

Completed

• Conditions: Brain Tumor

• Registration Number: NCT04536142
• Lead Sponsor: University of Nebraska

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2020-08-27
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-02
• Primary Completion: 2023-06-06
• Study Completion: 2023-06-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. 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

2. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain connectivity changes	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	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.

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States