NCT03678441

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress89%
Aug 2018Apr 2027

Study Start

First participant enrolled

August 17, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

8.7 years

First QC Date

September 18, 2018

Last Update Submit

November 5, 2025

Conditions

Liver and Intrahepatic Bile Duct Disorder

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

Group I (BrainCheck and paper and pen cognitive assessment)

EXPERIMENTAL

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 AssessmentProcedure: Cognitive Assessment

Group II (pen and paper and BrainCheck cognitive assessment)

ACTIVE COMPARATOR

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 AssessmentProcedure: Cognitive Assessment

Interventions

BrainCheck Cognitive AssessmentBEHAVIORAL

Receive BrainCheck cognitive assessment

Also known as: BrainCheck
Group I (BrainCheck and paper and pen cognitive assessment)Group II (pen and paper and BrainCheck cognitive assessment)
Cognitive AssessmentPROCEDURE

Receive pen and paper cognitive assessment

Group I (BrainCheck and paper and pen cognitive assessment)Group II (pen and paper and BrainCheck cognitive assessment)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Timothy Newhook, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 19, 2018

Study Start

August 17, 2018

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

November 10, 2025

Record last verified: 2025-11

Locations

US(1)