To investigate active and resting state networks and other MR parameters in patients with epilepsy and to determine the possible influence of anti-epileptic drugs use.
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences between the groups on network describing MR parameters, especially
fMRI, functional connectivity and spectroscopy; Relations between these
parameters with their anti-epileptic drug use.
Secondary outcome
The MR parameters and anti-epileptic drug use will be correlated with
neuropsychological test results and the results of the questionnaires.
Background summary
Anti-epileptic drugs have effects on brain functions. This sometimes leads to
tolerability problems in the form of cognitive side effects. fMRI and other MR
parameters can be used to study brain functions in detail, which may help us to
understand (changes in) brain function when using anti-epileptic drugs. We
hypothesize (1) that such differences can be observed on the level of
activation and functional connectivity between brain areas leading to changed
networks and (2) that the appearance of cognitive side effects induced by AED
treatment are related to changes in neurotransmitter concentration (GABA and/or
Glu).
Study objective
To investigate active and resting state networks and other MR parameters in
patients with epilepsy and to determine the possible influence of
anti-epileptic drugs use.
Study design
Observational and clinical comparative study, in patients with epilepsy. The
study is a proof of principal study. Seventy patients diagnosed with epilepsy
using anti-epileptic drugs that have developed subjective complaints about
their anti-epileptic drug treatment will be investigated. Half of them
(thirty-five) are using topiramate or phenytoin and the other half of them
(thirty-five) are using lamotrigine or levetiracetam. The groups will be
case-wise matched on important demographic factors: age, gender, educational
level and on co-medication (carbamazepine or valproate). MRI examination and a
neuropsychological investigation (including questionnaires) will be performed.
Study burden and risks
Besides the normal clinical evaluation the patient will undergo one
neuropsychological investigation and filling out some questionnaires once
(about 45 minutes in duration), one MR scanning session (about 60 minutes in
duration) and one blood sample. There is no extra benefit for the participating
patients themselves. The extra risks for the patients participating in this
study are less than minimal.
Postbus 61
5590 AB Heeze
NL
Postbus 61
5590 AB Heeze
NL
Listed location countries
Age
Inclusion criteria
Age over 18 years old, able to give informed consent, using anti-epileptic drugs (phenytoin, topiramate, levetiracetam or lamotrigine) when investigations take place.
Exclusion criteria
Absolute or relative contra-indications for MR scanning, unable to peform tasks in MR or unable to complete the questionnaires.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38718.068.11 |