|- candidate number||20865|
|- NTR Number||NTR4878|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-nov-2014|
|- Secondary IDs||142048 METC azM/UM|
|- Public Title||Onderzoek naar afwijkingen in het brein netwerk bij epilepsie|
|- Scientific Title||Characterization of neurotransmitter network dysfunction in MRI-negative localisation-related epilepsy|
|- hypothesis||Patients with MRI-negative localization related epilepsy have abnormalities in neurotransmitter concentrations extending over a larger portion of the brain than solely the epileptic focus. By applying a graph theoretical approach, the level of these abnormalities can be characterized.|
|- Healt Condition(s) or Problem(s) studied||Epilepsy|
|- Inclusion criteria||Subjects must be older than 18 years and able to give informed consent. Furthermore, for the epilepsy subjects the following criteria apply: |
- Diagnosed with cryptogenic localization-related epilepsy with an epileptic focus in the frontal or temporal lobe (using EEG)
- Seizure frequency below 13/year. We have chosen this arbitrary boundary of maximal 1 seizure a month to not include people with too high disease burden and possible consequently brain damage because of their frequent seizures.
- No changes in anti-epileptic drugs (medication or dose) in the last 6 months.
|- Exclusion criteria||- MRI visible lesions, as seen on the clinical 3T scans|
- All absolute or relative contraindications for MR scanning: e.g. metallic prostheses, pacemakers, neurostimulators, metal clips on blood vessels, metal parts in the eye, an intrauterine device, metal braces and other metal objects in the body; pregnancy and claustrophobia; tattoos.
- A medical history with cerebral diseases (other than epilepsy), vascular problems, diabetes mellitus, hypertension and/or cerebral surgery.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||4-nov-2014|
|- planned closingdate||1-mrt-2017|
|- Target number of participants||20|
|- Primary outcome||The network properties of the NAA/Cr and GABA/glu networks derived from MRSI. These network metrics include average node degree, characteristic path length and cluster coefficient. |
|- Secondary outcome||The relationship between the MRSI, fMRI and dMRI derived network properties. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| T. Veenendaal, van|
|- CONTACT for SCIENTIFIC QUERIES|| T. Veenendaal, van|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Universiteitsfonds Limburg (SWOL), Maastricht University|
|- Brief summary||Rationale: A large portion of patients with intractable epilepsy does not become completely seizure free after resection of the epileptic focus. This ineffectiveness might be due to the fact that epilepsy is not necessarily a purely focal disease, but rather is associated with widespread network alterations in the brain, for which deficient functional and structural networks have previously been shown in epilepsy patients. However, these networks do not provide direct information on the defective neurons or the linked neurotransmitter disbalance. We propose the novel application of graph theoretical analysis in magnetic resonance spectroscopic imaging, to provide insight into the neurotransmitter network dysfunction in MRI‐negative epilepsy. This will be of great value to eventually better understand the neuronal network characteristics of epilepsy and potentially the underlying mechanism of surgical failure in epilepsy.
Objective: To compare the neurotransmitter networks of patients with localisation-related epilepsy patients to those of healthy subjects; To explore the relationship between MRSI, fMRI & dMRI derived network properties, and relate these to clinical characteristics.
Study design: This is an observational study comparing epilepsy patients with healthy subjects. MRI measures of MRI-negative localization-related epilepsy patients will be compared to those of healthy subjects, matched for age, gender, and educational level. Each subject will undergo MRI measurements at one time point.
Study population: The study population consists of 10 adult MRI-negative localization-related epilepsy patients with an epileptic focus in the frontal or temporal lobe and 10 healthy controls.
Main study parameters/endpoints: The main study parameters are the neurotransmitter network properties of MRI-negative localization-related epilepsy patients compared to those of healthy subjects.
|- Main changes (audit trail)|
|- RECORD||3-nov-2014 - 1-dec-2014|