Prediction and recovery of cognitive impairment in neurosurgical patients.
- Conditions
- neuropsychologisch functionerencognitive impairment1002921110009720
- Registration Number
- NL-OMON55817
- Lead Sponsor
- Elisabeth-Tweesteden ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1230
The study sample will be composed of patients admitted for intracranial
neurosurgical treatment of brain tumours (e.g., meningiomas, adenomas, gliomas
or metastases), vascular compression syndromes (e.g., trigeminal neuralgia) or
lesions (e.g., aneurysms)., Eligible subjects for the control group are:
1) sociodemographically similar to the patient group
2) in good health, with no current or past psychiatric, neurologic, or
cognitive disorder, and mediation-use that interferes with cognitive function
Patients and Dutch control subjects will be excluded from participation in this
study:
1) if lack basic proficiency in Dutch
2) if their IQ is below 85 or if they have low cognitive skills
3) if their Karnovsky Performance Scale is under 60
4) if they are completely unfamiliar with the use of computers
5) if they have an additional (history of) a significant neurological or
psychiatric disorder
6) if there is no surgery-related complication (morbidity or mortality due to
e.g., thrombosis or heart attack)
[APOE substudy: objection against 'further use' of samples of previously drawn
blood]
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>[retrospective and prospective clinical path:<br /><br>- changes in objective cognitive performance from pre-surgery to post-surgery]<br /><br><br /><br>predict-substudy<br /><br>- changes in objective cognitive performance from pre-surgery to 24 months<br /><br>post-surgery<br /><br><br /><br>[HGG-substudy<br /><br>- changes in objective cognitive performance from pre-surgery to post-surgery<br /><br>- tumor progression according to the RANO criteria<br /><br><br /><br>APOE-substudy<br /><br>- APOE allele carrier status (at least 1 *4 allel versus *2 en *3)<br /><br>- cognitive functioning presurgery and 3 and 12 months postsurgery]</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters/endpoints<br /><br>- depression<br /><br>- anxiety<br /><br>- subjective cognitive complaints<br /><br>- pain<br /><br>- fatigue<br /><br>- social integration<br /><br>- work related functioning<br /><br>- (history of) smoking</p><br>