Neurocognitive functioning and brain plasticity in high-grade glioma patients: a magnetoencephalography pilot
| ISRCTN | ISRCTN73594603 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73594603 |
| Protocol serial number | NWOpilot01 |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Funder | Vrije University Medical Centre (VUMC) (The Netherlands) |
- 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
Scientific
Department of Medical Psychology, D343
Vrije University Medical Centre
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8432 |
|---|---|
| m.klein@vumc.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicentre, observational, case-control study |
| Secondary study design | Case-control study |
| Scientific title | |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Main study parameters are neurocognitive functioning and Magnetoencephalogram (MEG)-measures (synchronisation likelihood and small-world features). |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Medical Psychology, D343
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
