Evaluation of Changes in Brain Connectivity After Tumor Resection

NCT ID: NCT04536142

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-27
• Study Completion Date: 2023-06-06

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).

Conditions

Brain Tumor

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Brain tumors

Subjects with operable supratentorial brain tumors

MRI

Intervention Type: 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

Intervention Type: 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

Healthy subjects

Healthy subjects

MRI

Intervention Type: 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

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Great Plains IDeA-CTR

UNKNOWN

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele Aizenberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0155-20-EP

Identifier Type: -

Identifier Source: org_study_id