BrainCheck Cognitive Assessment for Liver Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Liver DiseaseBrainCheck Cognitive Assessment - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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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

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

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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