Electronic Neurocognitive Tools in Screening for Mental Capability in Patients Undergoing Liver Surgery
May 18, 2026 updated by: M.D. Anderson Cancer Center
A Feasibility Study of Electronic Neurocognitive Screening Tools in Surgery
This trial studies how well electronic neurocognitive tools work in screening for mental capability in patients who are undergoing liver surgery.
Using electronic neurocognitive screening tools may help to better assess mental impairment.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Evaluate feasibility of the electronic batteries, measured by the completion rate and time to completion of the batteries.
SECONDARY OBJECTIVES:
I. Comparison of the completion rate and time to completion between the written and electronic batteries.
II. Comparison of the scoring distribution between the screening tools.
EXPLORATORY OBJECTIVES:
I. Assess if a history of mental or cognitive illness or ongoing treatment with neuropsychiatric medications impact the ability to complete written and/or electronic neurocognitive screening.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen cognitive assessment within 2 months prior to surgery and within 2 months after surgery.
GROUP II: Patients receive the paper and pen cognitive assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- All English-speaking patients undergoing hepatectomy at main campus University of Texas (UT)-MD Anderson Cancer Center who are cognitively able to provide informed consent in the opinion of the attending physician.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I (BrainCheck and paper and pen cognitive assessment)
Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen assessment 2 months prior to surgery and within 2 months after surgery.
|
Receive BrainCheck cognitive assessment
Other Names:
Receive pen and paper cognitive assessment
|
|
Active Comparator: Group II (pen and paper and BrainCheck cognitive assessment)
Patients receive the paper and pen assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery.
|
Receive BrainCheck cognitive assessment
Other Names:
Receive pen and paper cognitive assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion rate of the BrainCheck battery
Time Frame: Up to 1 year
|
Will be calculated along with a 95% confidence interval (CI).
|
Up to 1 year
|
|
Completion rate of the pen and paper assessment
Time Frame: Up to 1 year
|
Will be calculated along with a 95% CI.
|
Up to 1 year
|
|
Average time to complete the BrainCheck battery
Time Frame: Up to 1 year
|
Will be calculated along with a 95% CI.
|
Up to 1 year
|
|
Average time to complete the pen and paper assessment
Time Frame: Up to 1 year
|
Will be calculated along with a 95% CI.
|
Up to 1 year
|
|
Difference in completion rate between the BrainCheck battery and paper and pen assessment
Time Frame: Up to 1 year
|
Will be calculated along with 95% CIs.
|
Up to 1 year
|
|
Difference in time to completion between the BrainCheck battery and the pen and paper assessment
Time Frame: Up to 1 year
|
Will be calculated along with 95% CIs.
|
Up to 1 year
|
|
Difference in score between the BrainCheck battery and the pen and paper assessments
Time Frame: Up to 1 year
|
Will be calculated along with 95% CIs.
|
Up to 1 year
|
|
Sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of the electronic battery compared to the validated St. Louis University Mental Status Examination (SLUMS)
Time Frame: Up to 1 year
|
Will be calculated along with 95% CIs.
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy Newhook, MD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2018
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Study Registration Dates
First Submitted
September 18, 2018
First Submitted That Met QC Criteria
September 18, 2018
First Posted (Actual)
September 19, 2018
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0093 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-01895 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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