Prediction and recovery of cognitive impairment in neurosurgical patients.

Prediction and recovery of cognitive impairment in neurosurgical patients. - Predict

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55817

Enrollment

1230

Registered

2012-12-17

Start date

2016-06-15

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuropsychologisch functioneren cognitive impairment

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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]

Design outcomes

Primary

Measure	Time frame
[retrospective and prospective clinical path: - changes in objective cognitive performance from pre-surgery to post-surgery] predict-substudy - changes in objective cognitive performance from pre-surgery to 24 months post-surgery [HGG-substudy - changes in objective cognitive performance from pre-surgery to post-surgery - tumor progression according to the RANO criteria APOE-substudy - APOE allele carrier status (at least 1 4 allel versus 2 en *3) - cognitive functioning presurgery and 3 and 12 months postsurgery]	—

Measure

Time frame

[retrospective and prospective clinical path: - changes in objective cognitive performance from pre-surgery to post-surgery] predict-substudy - changes in objective cognitive performance from pre-surgery to 24 months post-surgery [HGG-substudy - changes in objective cognitive performance from pre-surgery to post-surgery - tumor progression according to the RANO criteria APOE-substudy - APOE allele carrier status (at least 1 *4 allel versus *2 en *3) - cognitive functioning presurgery and 3 and 12 months postsurgery]

—

Secondary

Measure	Time frame
Secondary study parameters/endpoints - depression - anxiety - subjective cognitive complaints - pain - fatigue - social integration - work related functioning - (history of) smoking	—

Countries

Netherlands

Outcome results