We will investigate the changes in mental performance using a validated computerized test battery of neuropschychological tests just before and one year after transplantation. Using visual and auditory information stimuli, these tests measure speed…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in mental performance in kidney recipients at twelve months after
transplantation compared to pre-transplantation.
Secondary outcome
o The change in mental performance in kidney recipients at twelve months after
transplantation compared to the change in mental performance in kidney donors.
o Changes in cortical, hippocampal, temporal atrophy and global cerebral
atrophy, using both visual rating scales as well as volumetric analyses.
o Changes in white matter lesions using both visual rating scales as well as
volumetric analyses.
o Presence of microinfarctions and areas with microbleeding at baseline and
occurrence of new lesions during followup.
o Change in cerebral blood flow as measured by arterial spin labelling.
Background summary
Cognitive impairment is common in Chronic Kidney Disease (CKD) and is
associated with decreased quality of life, higher morbidity and mortality,
decreased medical adherence and increased medical costs. Early recognition of
impaired cognitive function is important because it enables health care
professionals to implement measures to improve coping and reduce deterioration.
This will improve quality of life, increase medical adherence to the often
complicated medication schemes and reduce health care costs.
Previously, it has been shown that in middle age, end-stage-renal-disease
(ESRD) patients, cognitive performance improves after renal transplantation.
However, no data exist whether this improvement in cognitive performance is
reflected by normalization of the abnormalities seen on MRI in chronic kidney
disease.
Study objective
We will investigate the changes in mental performance using a validated
computerized test battery of neuropschychological tests just before and one
year after transplantation. Using visual and auditory information stimuli,
these tests measure speed, stability and accuracy of various basic
neuropsychological processes underlying neurocognitive function, i.e. sustained
attention and executive functions such as working memory, inhibitory control
and cognitive flexibility. In addition, psychomotor functions will be
performed, as well as a POMS (profile of mood states) assessment and a verbal
fluency test.
We will compare the results of neuropsychological testing with neuro-imaging.
MRI scanning will be performed pre- and posttransplantation to assess white
matter lesions, brain atrophy, cerebral perfusion and specific intracerebral
lesions that are associated with neuropsychological deficits. To our knowledge,
there are no prospective studies in renal transplant patients that use both
neuropsychological testing and MRI scanning as tools to evaluate cognitive
function.
Study design
The design of the study is a prospective observational cohort study
Study burden and risks
negligible
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Patients undergoing a scheduled renal transplantation with a live kidney donor before having started dialysis or within one year after starting dialysis and their donors.
* Sufficient visual and hearing acuity
* Dutch or English language fluency
* Willingness to give informed consent
* ABO compatible
Exclusion criteria
* Pre-existing documented cognitive impairment
* A history of psychiatric illness
* Use of psychoactive substances
* A history of cerebrovascular disease (either transitory ischaemic attack or cerebrovascular accident)
* Brain injury
* Epilepsy
* Acute or chronic infections
* Malignancy
* Unstable coronary vascular disease
* Uncontrolled hypertension
* Liver disease or other metabolic disease leading to encephalopathy
* Diabetes mellitus
* Uncorrected anemia (Hb <7,0 mmol/L)
* MR contraindications, including implanted active devices or objects (e.g. cardiac pacemaker, implantable defibrillator, medication pump, intracranial aneurysm clips, cochlear implant and other implants), metal splinters near sensitive organs (e.g. eye, brain or lungs) or claustrophobia.
* Any condition that can be expected to interfere with complete follow-up
* Patients participating in group 1 of the ALLEGRO trial
* HLA-identical family transplantations
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41987.018.13 |