Cognitive Assessment for Liver Surgery Patients

Overseen By Timothy Newhook, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Non-English speakers, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of electronic tools in assessing mental skills in individuals undergoing liver surgery. It compares a digital test, the BrainCheck Cognitive Assessment, with the traditional paper-and-pen test to determine which better identifies mental issues. Participants will complete both tests before and after surgery. English-speaking individuals planning liver surgery at UT-MD Anderson Cancer Center may qualify. As an unphased trial, this study allows participants to contribute to innovative research that could enhance mental health assessments for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these cognitive assessment tools are safe for liver surgery patients?

Research has shown that BrainCheck, a tool for assessing brain function, is safe and easy to use. Studies have found it to be as accurate as the Montreal Cognitive Assessment (MoCA), a common test for brain health. This indicates that it functions effectively without causing harm. The tool has been tested with nearly 5,000 people of various ages and backgrounds, demonstrating its safety and usefulness for many. While specific safety details are not provided, its regular use in healthcare supports its safety for individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different cognitive assessment methods can better evaluate liver surgery patients. While traditional assessments often rely solely on paper and pen tests, this trial incorporates BrainCheck, a digital tool that provides quick, comprehensive cognitive evaluations in just 15 minutes. This combination aims to improve the accuracy and efficiency of cognitive assessments, potentially leading to better pre- and post-operative care for liver surgery patients. By comparing these methods, researchers hope to identify the most effective way to monitor cognitive changes, enhancing patient outcomes.

What evidence suggests that these cognitive assessment methods are effective for liver surgery patients?

Research has shown that the BrainCheck Cognitive Assessment matches the accuracy of the Montreal Cognitive Assessment (MoCA), a well-known tool for evaluating brain function. This confirms that BrainCheck can reliably measure mental abilities. It has been tested with a large group of 4,949 people, ensuring consistent results across different ages, genders, and education levels. In this trial, participants in Group I will first receive the BrainCheck cognitive assessment, followed by a paper-and-pen assessment. Participants in Group II will receive the paper-and-pen assessment first, followed by the BrainCheck cognitive assessment. Identifying cognitive issues in liver surgery patients is crucial, as it can affect their health outcomes. Effective tools like BrainCheck enable doctors to better understand and manage a patient's mental health before and after surgery. ^{1 4 6 7 8}

Who Is on the Research Team?

Timothy Newhook, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking patients at UT-MD Anderson Cancer Center who are about to have liver surgery and can give informed consent. It's designed to see if they're mentally sharp enough for the procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Assessment

Participants receive cognitive assessments (BrainCheck and paper and pen) 2 months prior to surgery

2 months

1 visit (in-person)

Post-Surgery Assessment

Participants receive cognitive assessments (BrainCheck and paper and pen) within 2 months after surgery

2 months

1 visit (in-person)

Follow-up

Participants are monitored for cognitive assessment outcomes up to 1 year

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• BrainCheck Cognitive Assessment
• Cognitive Assessment

Trial Overview The study is testing electronic tools called BrainCheck Cognitive Assessment to screen mental capability in patients before liver surgery, aiming to identify any cognitive impairments more effectively.

How Is the Trial Designed?

Group I: Group I (BrainCheck and paper and pen cognitive assessment) Experimental Treatment 2 Interventions

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.

Group II: Group II (pen and paper and BrainCheck cognitive assessment) Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10545399/

Cognitive function, self-management, and outcomes among ... The study will analyze data on patient and care partner outcomes and behavioral, knowledge, and clinical covariates.

2. braincheck.com braincheck.com/science/

Scientific Publications | Neurocognitive Testing Researchers confirmed BrainCheck Assess is as accurate as the widely-used Montreal Cognitive Assessment (MoCA), with equivalent cut-off scores showing strong ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/1526924820958144

Cognitive Function in Liver Transplant Recipients Who ... Studies have also demonstrated that patients with cognitive impairment were more likely to have worse health outcomes, such as higher ...

4. mecp.springeropen.com mecp.springeropen.com/articles/10.1186/s43045-022-00175-3

Cognitive impairment in recipients of liver transplantation and ... Patients with ESLD have significant cognitive impairment that showed improvement after LT; HE did not correlate with cognitive function. Hence, ...

5. braincheck.com braincheck.com/articles/news/braincheck-expands-normative-database-to-further-support-accuracy-and-consistency-in-cognitive-assessment/

BrainCheck Expands Normative Database to Further ... The updated dataset now includes results from 4,949 participants across a range of ages, genders, education levels, and U.S. regions. This ...

6. braincheck.com braincheck.com/articles/cognitive-clarity-after-surgery-brainchecks-role-in-upmcs-peri-op-workflow/

BrainCheck's Role in UPMC's Peri-Op Workflow With tools like BrainCheck, health systems can finally make cognitive assessments a routine part of safe, patient-centered care. Want to Learn ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9288500/

Perioperative Brain Health in the Older Adult: A Patient Safety ... Poor Performance on a Preoperative Cognitive Screening Test Predicts Postoperative Complications in Older Orthopedic Surgical Patients.

8. mdpi.com mdpi.com/1422-0067/26/16/7670

Circulating FGF-21 as a Disease-Modifying Factor ... Cognitive performance was evaluated through BrainCheck assessments. Among ME patients with high circulating FGF-21 levels, a significant negative correlation ...