search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Neurocognitive functioning and brain plasticity in high-grade glioma patients: a magnetoencephalography pilot


- candidate number2655
- NTR NumberNTR1016
- ISRCTNISRCTN73594603
- Date ISRCTN created23-aug-2007
- date ISRCTN requested13-aug-2007
- Date Registered NTR5-jul-2007
- Secondary IDsNWOpilot01 
- Public TitleNeurocognitive functioning and brain plasticity in high-grade glioma patients: a magnetoencephalography pilot
- Scientific TitleNeurocognitive functioning and brain plasticity in high-grade glioma patientsn: a magnetoencephalography pilot
- ACRONYMCognition & brain plasticity in HGG patients
- hypothesisWe hypothesize that a relationship is present between functional connectivity, network features and neurocognitive performance in GBM patients. We also expect treatment and recurrence of the tumor to lead to remodeling of the neuronosynaptic maps and network features (i.e. plasticity), and hypothesize that these dynamic changes correlate with improvements of cognition.
- Healt Condition(s) or Problem(s) studiedGlioma, high grade, Glioblastoma multiforme
- Inclusion criteriaFor newly diagnosed patients: 1. Adult (> 18 years), 2. Radiologically suspected GBM prior to surgery, 3. histologically confirmed GBM after surgery, 4. treatment consisting of surgery followed by combined radiotherapy and chemotherapy, 5. written informed consent. For patients with GBM recurrence: 1. adult (> 18 years), 2. histologically confirmed GBM, 3. treatment consisting of surgery followed by chemotherapy, 4. written informed consent. For matched healthy controls: 1. adult (> 18 years), 2. written informed consent.
- Exclusion criteriaFor patient groups: 1.use of centrally acting drugs, including corticosteroids, other than antiepileptic drugs, 2. psychiatric disease or symptoms, 3. insufficient mastery of the Dutch language, 4. inability to communicate adequately. For controls: 1. use of centrally acting drugs (including analgetics), 2. psychiatric disease or symptoms, 3. disorders of the central nervous system, 4. insufficient mastery of the Dutch language.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type-
- Studytypeintervention
- planned startdate 1-sep-2007
- planned closingdate1-jun-2008
- Target number of participants40
- InterventionsNot applicable.
- Primary outcomeMain study parameters are neurocognitive functioning and MEG-measures (synchronization likelihood and small-world features).
- Secondary outcomeNot applicable.
- Timepoints
- Trial web siteNot applicable.
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M. Klein
- CONTACT for SCIENTIFIC QUERIESDr. M. Klein
- Sponsor/Initiator VU University Medical Center, Department of Medical Psychology
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- Publications
- Brief summaryPatients with localized brain tumors, such as glioblastoma multiforme, often suffer from diffuse cognitive deficits. It is difficult to understand how such a local brain lesion gives rise to non-specific, diffuse cognitive deficits. Evidence has accumulated that higher cognitive functions require functional interactions, or connectivity, between multiple distinct neural networks. An optimal neuronal network architecture is probably characterized by so-called 'small-world' characteristics, combining high local connectivity with efficient overall integration. By using magnetoencephalography (MEG), which has proven to be an excellent way to capture the dynamics of the electromagnetic fields of the brain, we recently found that brain tumor patients not only have altered levels of synchronization throughout the brain, but also that these alterations correlate with neurocognitive functioning. It is unknown, however, to what extent remodeling of the neurosynaptic networks (i.e: cerebral plasticity), varies as a function of treatment (i.e., surgery, radiotherapy, chemotherapy) and tumor recurrence. Using prospective cognitive data and MEG recordings of ten newly diagnosed glioblastoma multiforme patients and ten glioblastoma multiforme patients with tumor recurrence we will investigate 1) the impact of tumor- and treatment-related factors on functional connectivity and neural network features, and 2) the correlation between changes in these measures and cognitive function. If such treatment- and/or tumor-related cerebral plasticity and its correlation with cognition can be established in this pilot, future prospective studies will focus in more detail on 1) the effects of different treatment modalities (e.g. less or more extensive surgery, radiotherapy) and 2) the contribution of tumor-related symptoms (e.g. epilepsy) and their treatment (e.g. anti-epileptic drugs) on neural network function and cognition. This knowledge will eventually assist in the guidance of clinical decision-making in these patients.
- Main changes (audit trail)
- RECORD5-jul-2007 - 27-aug-2007


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl