1) Evaluating the effect and recovery of glioma surgery in eloquent areas on cognitive functioning.2) Examining the effec tof glioma surgery in eloquent areas on quality of life.3) Examining the effect of gliomas in eloquent areas on the…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) The change and recovery in performance in the main neuropsychological
domains (language, memory, attention, executive functions, visuoconstruction,
praxis) as measured with standardized neuropsychological tests.
2) Change in perceived quality of life, as measured with QoL questionnaires.
Secondary outcome
For the neuropsychological study:
1) The influence of tumor characteristics (localization, histological type,
pathological grade (WHO) and volume).
2) The influence of the extent of the resection.
3) The influence of (type and dose of) antiepileptic medication.
4) The influence of (type and dose of) postsurgical treatment, with either
radiotherapy, chemotherapy, or both.
Background summary
Cognitive performance is an important outcome measure of brain tumor treatment,
as neuropsychological deficits have an impact on quality of life (Le Rhun,
Delbeuck, Devos, Pasquier & Dubois 2009). Previous neuropsychological studies
found that the majority of low-grade glioma patients have deficits in one or
more cognitive domains such as language, executive functions, verbal and
nonverbal memory and processing speed (Tucha, Smely, Preier & Lange, 2000). The
presence and severity of cognitive disorders is one of the main factors in the
decision-procedure of awake-operations. However, the effect of surgery on these
cognitive deficits still needs further investigation. In the present
exploratory study, a comprehensive assessment of cognitive functioning will be
performed before and after awake craniotomy.
Study objective
1) Evaluating the effect and recovery of glioma surgery in eloquent areas on
cognitive functioning.
2) Examining the effec tof glioma surgery in eloquent areas on quality of life.
3) Examining the effect of gliomas in eloquent areas on the localisation of
receptive and productive language areas.
4) Examining the effect of glioma surgery in eloquent areas on the localisation
of receptive and productive language areas.
Study design
A longitudinal observational study.
Study burden and risks
Neuropsychological assessment: No risks are associated with participation,
besides fatigue due to the neuropsychological examination. Patients may benefit
from participation as they will get feedback about their performance and advice
about postoperative neurocognitive revalidation if they wish so.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Neuropsychological study:
- Untreated or recurrent lesion in or near eloquent brain areas
- At preoperative diagnosis: presumed low grade glioma
- 18-65 years old
- Fluent in speaking and understanding the Dutch language
Exclusion criteria
- History of a medical, neurological or psychiatric condition known to affect cognitive
functioning
- (History of) substance abuse
- Suffering from permanent cognitive or motor problems caused by previous surgery
- Risk factors for awake surgery
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 | NL33484.078.10 |