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NCT Number: NCT03678441

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Liver and Intrahepatic Bile Duct Disorder Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BrainCheck Cognitive Assessment

Behavioral

Receive BrainCheck cognitive assessment

Other names: BrainCheck

cognitive assessment

Procedure

Receive pen and paper cognitive assessment

Primary outcomes

  1. Completion rate of the BrainCheck battery

    Time frame: Up to 1 year

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

  2. Completion rate of the pen and paper assessment

    Time frame: Up to 1 year

    Will be calculated along with a 95% CI.

  3. Average time to complete the BrainCheck battery

    Time frame: Up to 1 year

    Will be calculated along with a 95% CI.

  4. Average time to complete the pen and paper assessment

    Time frame: Up to 1 year

    Will be calculated along with a 95% CI.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Feasibility Study of Electronic Neurocognitive Screening Tools in Surgery

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2018
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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