Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619106
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Development of a Cognitive Tool for Rapid and Reliable Screening of Minimal Hepatic Encephalopathy Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of a Cognitive Tool for Rapid and Reliable Screening of Minimal Hepatic Encephalopathy Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLOCK-HE
Brief Summary:
The aim of this project is to evaluate the sensitivity and specificity of a cognitive test toward the presence of minimal hepatic encephalopathy MHE MHE is a neurological complication due to hepatic dysfunction andor the presence of porto-systemic shunts defined by the presence of neurocognitive impairments NI Other factors of brain injury may cause NI independently from the liver condition making the differential diagnosis difficult using available cognitive tests ANT Animal Naming Test PHES Psychometric Hepatic Encephalopathy Score CFF Critical Flicker Frequency test The cognitive test evaluated in this project is a construction task using construction blocks allowing the evaluation of psychomotor speed executive functions attention and episodic memory The measures will be compared to other cognitive tests validated for the evaluation of the targeted cognitive functions PHES Mesulam Cancelling task Rey-Osterrieth complex figure Free and Cued Selective Reminding Test and cognitive tests validated for the diagnosis of MHE PHES ANT CFF The diagnosis of MHE is based on an adjudication committee including a multimodal assessment of MHE brain MRI with spectroscopy EEG blood sample neuropsychological assessment allowing the evaluation of comorbidities such as other factors of brain injury
Detailed Description:
Hepatic encephalopathy HE corresponding to all the neurocognitive symptoms caused by liver damage andor the presence of portosystemic shunts HE can take several forms depending on its intensity ranging from subtle neuropsychological abnormalities that are difficult to detect during a routine interview minimal HE MHE to temporospatial disorientation and confusion that can lead to coma overt HE OHE MHE can significantly impair the quality of life of patients and caregivers it is associated with a poorer prognosis of liver pathology and a significantly more frequent occurrence of OHE Detection of MHE is complex and involves the convergence of a large number of tests recognized as sensitive venous ammonia level electroencephalogram MRI with spectroscopy complete neuropsychological assessment Today there is no unanimously recognized Gold Standard
The objective of this research project is to develop a cognitive test to detect HE sensitively and specifically in order to detect HE
To do this the investigators will evaluate the qualities of a rapid and accessible test It is a test made up of building blocks to assess psychomotor speed attention executive functions and episodic memory If it proves sensitive and specific enough for the diagnosis of MHE it could be disseminated and allow the screening of MHE
To do this the investigators will compare the block construction test to other neuropsychological examinations validated in the diagnosis of MHE PHES Psychometric Hepatic Encephalopathy Score CFF Critical Flicker Frequency test ANT Animal Naming Test These examinations are reference cognitive tests in the diagnosis of MHE but the results between these tests diverge and do not currently make it possible to replace all of the clinical examinations described above The investigators will also compare the construction block test to cognitive tests validated for the evaluation of the targeted cognitive functions ROCF Rey-Osterrieth complex figure FCSRT Free and Cued Selective Reminding test MCT Mesulam cancelling task The diagnosis of MHE is based on an adjudication committee including a multimodal assessment of MHE brain MRI with spectroscopy EEG blood sample neuropsychological assessment allowing the evaluation of comorbidities such as other factors of brain injury
Main objective to evaluate the sensitivity and specificity of the construction test to the presence of MHE
Secondary objectives
1 Comparison of screening qualities of the construction test to MHE diagnosis validated tests PHES CFF ANT
2 Evaluate the impact of the presence of comorbidities factors of brain injury in the results of the construction test
3 Evaluate the psychometric qualities of the construction test compared to validated neuropsychological tests
The objective of this research project is to develop a cognitive test to detect HE sensitively and specifically in order to detect HE
To do this the investigators will evaluate the qualities of a rapid and accessible test It is a test made up of building blocks to assess psychomotor speed attention executive functions and episodic memory If it proves sensitive and specific enough for the diagnosis of MHE it could be disseminated and allow the screening of MHE
To do this the investigators will compare the block construction test to other neuropsychological examinations validated in the diagnosis of MHE PHES Psychometric Hepatic Encephalopathy Score CFF Critical Flicker Frequency test ANT Animal Naming Test These examinations are reference cognitive tests in the diagnosis of MHE but the results between these tests diverge and do not currently make it possible to replace all of the clinical examinations described above The investigators will also compare the construction block test to cognitive tests validated for the evaluation of the targeted cognitive functions ROCF Rey-Osterrieth complex figure FCSRT Free and Cued Selective Reminding test MCT Mesulam cancelling task The diagnosis of MHE is based on an adjudication committee including a multimodal assessment of MHE brain MRI with spectroscopy EEG blood sample neuropsychological assessment allowing the evaluation of comorbidities such as other factors of brain injury
Main objective to evaluate the sensitivity and specificity of the construction test to the presence of MHE
Secondary objectives
1 Comparison of screening qualities of the construction test to MHE diagnosis validated tests PHES CFF ANT
2 Evaluate the impact of the presence of comorbidities factors of brain injury in the results of the construction test
3 Evaluate the psychometric qualities of the construction test compared to validated neuropsychological tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None