Contact information
Type
Scientific
Primary contact
Dr M. Klein
ORCID ID
Contact details
Department of Medical Psychology
D343
Vrije University Medical Centre
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8432
m.klein@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NWOpilot01
Study information
Scientific title
Acronym
Study hypothesis
We hypothesise that a relationship is present between functional connectivity, network features and neurocognitive performance in Glioblastoma Multiforme (GBM) patients. We also expect treatment and recurrence of the tumour to lead to remodelling of the neuronosynaptic maps and network features (i.e. plasticity), and hypothesise that these dynamic changes correlate with improvements of cognition.
Ethics approval
Ethics approval received from ethics boards of two centres participating in the study:
1. Academic Medical Centre (AMC) Medisch Ethische Commissie, received on the 16th July 2007 (ref: MEC 07/134)
2. VU University Medical Center Medical Ethical Board, received on the 12th June 2007 (ref: 2007/108)
Study design
Multicentre, observational, case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Glioblastoma multiforme, high grade Glioma
Intervention
Using prospective cognitive data and MEG recordings of ten newly diagnosed glioblastoma multiforme patients and ten glioblastoma multiforme patients with tumour recurrence we will investigate:
1. The impact of tumour- 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 tumour-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 tumour-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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Main study parameters are neurocognitive functioning and Magnetoencephalogram (MEG)-measures (synchronisation likelihood and small-world features).
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2007
Overall trial end date
01/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
For newly diagnosed patients:
1. Adult (greater than 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 (greater than 18 years)
2. Histologically confirmed GBM
3. Treatment consisting of surgery followed by chemotherapy
4. Written informed consent
For matched healthy controls:
1. Adult (greater than 18 years)
2. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
For 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 analgesics)
2. Psychiatric disease or symptoms
3. Disorders of the central nervous system
4. Insufficient mastery of the Dutch language
Recruitment start date
01/09/2007
Recruitment end date
01/06/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Medical Psychology, D343
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Department of Medical Psychology
Amsterdam
1081 BT
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Vrije University Medical Centre (VUMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary