NCT04536142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

August 27, 2020

Last Update Submit

September 27, 2023

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

Brain tumors

Subjects with operable supratentorial brain tumors

Diagnostic Test: MRIDiagnostic Test: neuropsychological tests and qualitative assessment

Healthy subjects

Healthy subjects

Diagnostic Test: MRIDiagnostic Test: neuropsychological tests and qualitative assessment

Interventions

MRIDIAGNOSTIC_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.

Brain tumorsHealthy subjects
neuropsychological tests and qualitative assessmentDIAGNOSTIC_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

Brain tumorsHealthy subjects

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Oncologists and neurosurgeons may identify their patients for potential inclusion as brain tumor subjects. The "word-of-mouth" approach will be used to identify potential healthy subjects for this study.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Michele Aizenberg, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 2, 2020

Study Start

August 27, 2020

Primary Completion

June 6, 2023

Study Completion

June 6, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)