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Active, not recruitingNCT03678441ClinicalTrials.gov record

Electronic Neurocognitive Tools in Screening for Mental Capability in Patients Undergoing Liver Surgery

Liver and Intrahepatic Bile Duct Disorder

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
100 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
No masking
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.

Behavioral: BrainCheck Cognitive Assessment · Procedure: Cognitive Assessment

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.

Behavioral: BrainCheck Cognitive Assessment · Procedure: Cognitive Assessment

BrainCheck Cognitive Assessment BEHAVIORAL

Receive BrainCheck cognitive assessment

Cognitive Assessment PROCEDURE

Receive pen and paper cognitive assessment

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Completion rate of the BrainCheck battery

Time frame: Up to 1 year

Will be calculated along with a 95% confidence interval (CI).

Completion rate of the pen and paper assessment

Time frame: Up to 1 year

Will be calculated along with a 95% CI.

Average time to complete the BrainCheck battery

Time frame: Up to 1 year

Will be calculated along with a 95% CI.

Average time to complete the pen and paper assessment

Time frame: Up to 1 year

Will be calculated along with a 95% CI.

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.

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.

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.

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

M D Anderson Cancer CenterHouston, Texas, United StatesStatus unknown

Study team and timeline

Lead sponsor
M.D. Anderson Cancer Center
Study start
Aug 17, 2018 Actual
Primary completion
Apr 30, 2027 Estimated
Study completion
Apr 30, 2027 Estimated
First posted
Sep 19, 2018 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

A Feasibility Study of Electronic Neurocognitive Screening Tools in Surgery

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026