Minimal Hepatic Encephalopathy Clinical Trial
NCT number | NCT02767622 |
Other study ID # | 875 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | May 7, 2016 |
Last updated | May 9, 2016 |
Start date | June 2014 |
Verified date | May 2016 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Observational |
This study included 20 patients listed for liver transplantation in addition to 20 age- and sex- matched controls. Neurological, psychiatric, laboratory and radiological examinations were performed for both patients and controls before and 6 months after liver transplantation. Assessment of cognitive functions by Trail Making Test A (TMT A), TMT B, Digit Symbol Test (DST), and Serial Dotting Test (SDT) was done before and after liver transplantation.
Status | Completed |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation Exclusion Criteria: - Overt hepatic encephalopathy. - Significant cortical atrophy or other structural brain changes revealed by conventional neuro-imaging. - Regular use of psychotropic drugs, such as benzodiazepines. - Known major psychiatric disorder. - Less than 6 months of complete alcohol abstinence. - Post-transplant toxic levels of immunosuppressive drugs. - Patients unable to perform the tests (Illiterate or upper limb motor handicaps). |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of Psychometric tests. | 6 months following liver transplantation. | Yes | |
Secondary | Improvement of liver functions and MELD score following liver transplantation. | 6 months following liver transplantation. | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
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