Evaluation of Changes in Brain Connectivity After Tumor Resection

University of Nebraska

Status: Completed

Conditions: Brain Tumor

Treatments: Diagnostic Test: neuropsychological tests and qualitative assessment; Diagnostic Test: MRI

Study type: Observational

Funder types: Other

Identifiers

NCT04536142

0155-20-EP

Details and patient eligibility

About

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.

Full 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).

Enrollment: 43 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

43 participants in 2 patient groups

Brain tumors

Description:

Subjects with operable supratentorial brain tumors

Treatment:

Diagnostic Test: MRI

Diagnostic Test: neuropsychological tests and qualitative assessment

Healthy subjects

Description:

Healthy subjects

Treatment:

Diagnostic Test: MRI

Diagnostic Test: neuropsychological tests and qualitative assessment