Liver and Intrahepatic Bile Duct DisorderNCT03678441
Electronic Neurocognitive Tools in Screening for Mental Capability in Patients Undergoing Liver Surgery
A study testing BrainCheck Cognitive Assessment and Cognitive Assessment in people with Liver and Intrahepatic Bile Duct Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver and Intrahepatic Bile Duct Disorder
- What is being tested?
- BrainCheck Cognitive Assessment and Cognitive Assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2018to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate feasibility of the electronic batteries, measured by the completion rate and time to completion of the batteries.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Being tested
- BrainCheck Cognitive Assessment, Cognitive Assessment
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainCheck Cognitive AssessmentBehavioural
Also called BrainCheck
Receive BrainCheck cognitive assessment
Cognitive AssessmentProcedure or surgery
Receive pen and paper cognitive assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BrainCheck Cognitive Assessment; Procedure: 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. Receives: Behavioral: BrainCheck Cognitive Assessment; Procedure: Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of the BrainCheck battery
Will be calculated along with a 95% confidence interval (CI).
Measured: Up to 1 year
Completion rate of the pen and paper assessment
Will be calculated along with a 95% CI.
Measured: Up to 1 year
Average time to complete the BrainCheck battery
Will be calculated along with a 95% CI.
Measured: Up to 1 year
Average time to complete the pen and paper assessment
Will be calculated along with a 95% CI.
Measured: Up to 1 year
Difference in completion rate between the BrainCheck battery and paper and pen assessment
Will be calculated along with 95% CIs.
Measured: 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.
Measured: Up to 1 year
Difference in score between the BrainCheck battery and the pen and paper assessments
Will be calculated along with 95% CIs.
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start17 Aug 2018
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver and Intrahepatic Bile Duct DisorderStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Timothy Newhook, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678441
- Sponsor's protocol ID
- 2018-0093
- Other IDs
- NCI-2018-01895, 2018-0093
- Status last verified
- May 2026
- First submitted
- 18 Sep 2018
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Electronic Neurocognitive Screening Tools in Surgery
- ClinicalTrials.gov ID
- NCT03678441
- Acronym / sponsor ID
- 2018-0093
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate feasibility of the electronic batteries, measured by the completion rate and time to completion of the batteries.
SECONDARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (BrainCheck and paper and pen cognitive assessment) | Experimental | Behavioral: BrainCheck Cognitive Assessment, Procedure: Cognitive AssessmentPatients 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. |
| Group II (pen and paper and BrainCheck cognitive assessment) | Active comparator | Behavioral: BrainCheck Cognitive Assessment, Procedure: Cognitive AssessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainCheck Cognitive AssessmentAlso: BrainCheckReceive BrainCheck cognitive assessment | Behavioural | Group I (BrainCheck and paper and pen cognitive assessment), Group II (pen and paper and BrainCheck cognitive assessment) |
| Cognitive AssessmentReceive pen and paper cognitive assessment | Procedure or surgery | Group I (BrainCheck and paper and pen cognitive assessment), Group II (pen and paper and BrainCheck cognitive assessment) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Newhook, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainCheck Cognitive Assessment and Cognitive Assessment in people with Liver and Intrahepatic Bile Duct Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate of the BrainCheck battery (time frame: Up to 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026; AzTrials last refreshed its copy on 4 Nov 2026.