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.
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Network describing MR parameters, especially
fMRI and functional connectivity; Relations between these parameters and
changes in anti-epileptic drugs used.
Secondary outcome
The MR parameters and anti-epileptic drug use will be correlated with
neuropsychological test results.
Background summary
Rationale: Anti-epileptic drugs have effects on brain functions. This sometimes
leads to tolerability problems in the form of 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 that such changes can be observed on the level of activation and
functional connectivity between brain areas leading to changed networks.
Study objective
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
Study design: Observational and clinical comparative study, in patients with
epilepsy.
The study is a proof of principal study. About fifty patients diagnosed with
epilepsy using medication and developing objectively defined side effects will
be investigated. The MR parameters will be correlated with the disappearing of
the complaints and changes in neuropsychological test results after stopping
the drug. When our hypotheses seem valid, we will see changes in the networks.
Study burden and risks
Besides the normal clinical evaluation the patient will undergo two MR scanning
sessions (about 45 minutes in duration), two neuropsychological investigations
(about 30 minutes in duration), two blood samples and filling out some
questionnaires twice (about 10 minutes in duration). 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
Nederland
Postbus 61
5590 AB Heeze
Nederland
Listed location countries
Age
Inclusion criteria
Age over 18 years old, able to give informed consent, using anti-epileptic drugs 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 | NL22849.068.09 |