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

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: Liver and Intrahepatic Bile Duct Disorder
• Intervention / Treatment: Behavioral: BrainCheck Cognitive Assessment; Procedure: Cognitive Assessment

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

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	Behavioral: BrainCheck Cognitive Assessment; Receive BrainCheck cognitive assessment; Other Names: BrainCheck; Procedure: Cognitive Assessment; 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.	Behavioral: BrainCheck Cognitive Assessment; Receive BrainCheck cognitive assessment; Other Names: BrainCheck; Procedure: Cognitive Assessment; 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	Will be calculated along with a 95% confidence interval (CI).	Up to 1 year
Completion rate of the pen and paper assessment	Will be calculated along with a 95% CI.	Up to 1 year
Average time to complete the BrainCheck battery	Will be calculated along with a 95% CI.	Up to 1 year
Average time to complete the pen and paper assessment	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	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	Will be calculated along with 95% CIs.	Up to 1 year
Difference in score between the BrainCheck battery and the pen and paper assessments	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)	Will be calculated along with 95% CIs.	Up to 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Timothy Newhook, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

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: Digestive System Diseases; Biliary Tract Diseases; Digestive System Diseases; Behavioral Disciplines and Activities; Psychological Tests; Neuropsychological Tests; Mental Status and Dementia Tests
• 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