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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR1895 |
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Date of registration:
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06/07/2009 |
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Primary sponsor: |
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Public title:
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Localized epilepsy and neural networks.
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Scientific title:
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Lesional epilepsy: the effects of surgical intervention on ictal onset zone and permissive neural networks. - LESION |
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Date of first enrolment:
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9/7/2009 |
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Target sample size:
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40 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1895 |
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Study type:
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observational |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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E.
Dellen, van |
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Address:
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Postbus 7057, Department of Neurology - ZH 1F.003/005
VU Medisch Centrum
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20-4444234 |
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Email:
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Affiliation:
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Name:
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E.
Dellen, van |
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Address:
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Postbus 7057, Department of Neurology - ZH 1F.003/005
VU Medisch Centrum
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20-4444234 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria for pharmacoresistant epilepsy patients are:
1. Adult ( 18 years);
2. Patients who undergo resective surgical treatment at the VUmc regarding the Dutch Collaborative Epilepsy Surgery Program;
3. Have given written informed consent.
For brain tumour patients with epilepsy, inclusion criteria are:
1. Adult ( 18 years);
2. Patients who undergo resective surgical treatment of the tumour with epilepsy surgery techniques at the VUmc;
3. Are suffering from epilepsy which was not pre-existent to the lesion;
4. Have given written informed consent.
Exclusion criteria: Exclusion criteria are:
1. Psychiatric disease or symptoms;
2. Insufficient mastery of the Dutch language;
3. Inability to communicate adequately.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Glioma, Brain tumor, Epilepsy
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Primary Outcome(s)
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The main study parameters are a ECoG and MEG-based measures, assessing functional connectivity (SL and PLI) and neuronal brain networks (cluster coefficient and path length), seizure frequency and epilepsy burden.
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Source(s) of Monetary Support
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Netherlands Epilepsy Foundation (NEF)
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