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

ISRCTN ISRCTN73594603
DOI https://doi.org/10.1186/ISRCTN73594603
Secondary identifying numbers NWOpilot01
Submission date
23/08/2007
Registration date
23/08/2007
Last edited
01/10/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M. Klein
Scientific

Department of Medical Psychology, D343
Vrije University Medical Centre
Amsterdam
1081 BT
Netherlands

Phone +31 (0)20 444 8432
Email m.klein@vumc.nl

Study information

Study designMulticentre, observational, case-control study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeScreening
Scientific title
Study objectivesWe 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(s)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)
Health condition(s) or problem(s) studiedGlioblastoma multiforme, high grade Glioma
InterventionUsing 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 typeOther
Primary outcome measureMain study parameters are neurocognitive functioning and Magnetoencephalogram (MEG)-measures (synchronisation likelihood and small-world features).
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/09/2007
Completion date01/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants40
Key inclusion criteriaFor 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
Key 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 analgesics)
2. Psychiatric disease or symptoms
3. Disorders of the central nervous system
4. Insufficient mastery of the Dutch language
Date of first enrolment01/09/2007
Date of final enrolment01/06/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Department of Medical Psychology, D343
Amsterdam
1081 BT
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre

Department of Medical Psychology
Amsterdam
1081 BT
Netherlands

Website http://www.vumc.nl/english/
ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Hospital/treatment centre

Vrije University Medical Centre (VUMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan