Evaluation of Changes in Brain Connectivity After Tumor Resection

Brain Tumor Clinical Trial

Official title:

Evaluation of Changes in Brain Connectivity After Tumor Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536142
• Other study ID #: 0155-20-EP
• Status: Completed
• Start date: August 27, 2020
• Est. completion date: June 6, 2023

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 6, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Diagnostic Test:
• 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.
• 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

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Great Plains IDeA-CTR

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain connectivity changes	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.	MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery.
Primary	Neurocognitive changes	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.	Cognitive tests will be performed within 1 week prior to surgery and again 2 weeks after surgery.