Study Summary
This trial is testing how well electronic neurocognitive tools can screen for mental capability in patients who are undergoing liver surgery. The hope is that these tools will be able to better assess mental impairment.
Eligible Conditions
- Liver Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
8 Primary · 0 Secondary · Reporting Duration: Up to 1 year
Up to 1 year
Average time to complete the BrainCheck battery
Average time to complete the pen and paper assessment
Completion rate of the BrainCheck battery
Completion rate of the pen and paper assessment
Difference in completion rate between the BrainCheck battery and paper and pen assessment
Difference in score between the BrainCheck battery and the pen and paper assessments
Difference in time to completion between the BrainCheck battery and the pen and paper assessment
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)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Group II (pen and paper and BrainCheck cognitive assessment)
1 of 2
Group I (BrainCheck and paper and pen cognitive assessment)
1 of 2
Active Control
Experimental Treatment
100 Total Participants · 2 Treatment Groups
Primary Treatment: BrainCheck Cognitive Assessment · No Placebo Group · N/A
Group I (BrainCheck and paper and pen cognitive assessment)Experimental Group · 2 Interventions: Cognitive Assessment, BrainCheck Cognitive Assessment · Intervention Types: Procedure, Behavioral
Group II (pen and paper and BrainCheck cognitive assessment)ActiveComparator Group · 2 Interventions: Cognitive Assessment, BrainCheck Cognitive Assessment · Intervention Types: Procedure, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Assessment
2011
Completed Phase 2
~1250
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,099 Previous Clinical Trials
41,145,687 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,810 Previous Clinical Trials
1,790,471 Total Patients Enrolled
Timothy Newhook, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
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Conditions
Cancer Related
Treatments